FCC ID: SVHBAROSTIMPGM2 Model 9020 BAROSTIM PGM

 

System Overview

Caution: Federal law restricts this device to sale by or on the order of a physician.

0

ABOUT THIS DOCUMENT

This document is a portion of the Instructions for Use (IFU) for the Barostim NEO™ &

NEO2™ Systems. The full IFU consists of:

System Overview

Surgical Procedures

Programming

Patient Instructions

900133-001

900133-002

900133-003

900133-005

IFU documents are available at www.cvrx.com/ifu

1



Table of Contents

About this document ............................................................................... 1

1

System Description ................................................................................. 3

Implantable Pulse Generator (IPG) .............................................................. 5

Carotid Sinus Lead (CSL) kit ...................................................................... 5

Programmer System (PGM) ........................................................................ 5

Optional Accessories for Use with the System ................................................. 6

2

3

Symbols and Definitions ........................................................................... 7

Indications and Contra-indications ............................................................. 9

Indications: ......................................................................................... 10

Contraindications: ................................................................................. 10

4 Warnings and Precautions ....................................................................... 11

General .............................................................................................. 12

IPG ................................................................................................... 14

CSL ................................................................................................... 16

Programmer ........................................................................................ 17

Implant Adapter, Implant Tool .................................................................. 17

5 Adverse Events .................................................................................... 19

6 Clinical Summary ................................................................................. 22

7

Physician and Training Experience ............................................................ 37

Training Requirements ........................................................................... 38

8

Emergency Personnel Information ............................................................. 39

Radiopaque Identifier ............................................................................. 40

ECG Artifact ........................................................................................ 40

Temporarily Inhibiting the IPG Output ......................................................... 40

9 Warranty & Disclaimer of Warranty .......................................................... 41

10 Specifications ..................................................................................... 43

Implantable Pulse Generator .................................................................... 44

Lead (Models 1036 and 1037) .................................................................... 46

Carotid Sinus Lead Repair Kit .................................................................... 47

Programmer System ............................................................................... 48

11 Regulatory Notices ............................................................................... 52

12 Electromagnetic Compatibility Declarations ................................................. 54

Programmer System EMC Precautions .......................................................... 55

Programmer System RF Specifications ......................................................... 61

2



1

System Description

3

The Barostim NEO™ & NEO2™ Systems include the following components:

Description

Implantable Pulse Generator

Implantable Pulse Generator

Carotid Sinus Lead

Carotid Sinus Lead

Programmer System

Programmer System

Carotid Sinus Lead Repair Kit

Model Number

2102

2104

1036

1037

9010

9020

5010

The Barostim NEO & NEO2 Systems

are minimally-invasive using CVRx®

patented Barostim™ technology.

The Barostim systems are designed

to electrically activate the carotid

baroreceptors, the body’s natural

cardiovascular regulation sensors.

When the baroreceptors are

activated, signals are sent through

neural pathways to the brain and

interpreted as a rise in blood

pressure. The brain works to

counteract this perceived rise in

blood pressure by sending signals to

other parts of the body (heart,

blood vessels, and kidneys) that

relax the blood vessels and inhibit

the production of stress-related

hormones.

Therapy:

Therapy is generated by the Implanted

Pulse Generator (IPG) through the

Carotid Sinus Lead (CSL). The therapy is

an electrical pulse train of programmed

frequency, pulse width, and constant

current amplitude. Therapy can be

programmed to deliver up to three

different therapies scheduled in different

daily time windows.

Intended Users:

The system implantation, programming

and operation is managed by the

patient’s care team. This may be

individually or any combination of

Cardiologists, Hypertension Specialists,

Nephrologists, Heart Failure Specialists,

Electrophysiologists, or Vascular

Surgeons.

.

4



IMPLANTABLE PULSE GENERATOR (IPG)

MODEL 2102 OR 2104

The Implantable Pulse Generator (IPG) contains a battery and

circuitry in a hermetic enclosure. It provides control and delivery

of Barostim through the Carotid Sinus Lead to the baroreceptors.

The carotid sinus lead is attached to the pulse generator through

the connector module. Model 2102 has two lead connections;

Model 2104 has one lead connection.

CAROTID SINUS LEAD (CSL) KIT

MODEL 1036 OR 1037

The Carotid Sinus Lead conducts Barostim from the IPG to

the baroreceptors located on the carotid sinus. The leads

are available in two (2) models that only differ in length;

Model 1036 (40cm), and Model 1037 (50cm). Both are

supplied with a 2 mm electrode and CVRx’s implant tool and

implant adapter. The lead models are fully interchangeable

to allow for anatomical variations and to be used per the

physician’s discretion.

PROGRAMMER SYSTEM

(PGM)

The Programmer System allows

noninvasive adjustment of therapy

parameters and retrieves information

regarding the status of the IPG.

The Programmer System is available in

two different models the Model 9010

and the Model 9020. Both models

include the following major

components:

• Programmer Software

• Programmer Interface

• Computer/Tablet

PGM Programmer Software/Computer

The Programmer Software is installed on the supplied

Computer or Tablet. A USB memory device may be used

for file transfers to and from the Computer.

PGM Programmer Interface

The Programmer Interface, powered via the USB

connection, provides the telemetry interface to the IPG.

5

OPTIONAL ACCESSORIES FOR USE WITH THE SYSTEM

CSL Repair Kit Model 5010

The CVRx CSL Repair Kit contains tools and material to repair damage to the conductor

coils of a healed in therapy lead.

6



2

Symbols and

Definitions

7



Caution, Consult Accompanying Documents

Consult Instructions for Use

Do Not Reuse

Do Not Resterilize

Temperature Limitation

Date of Manufacture

Manufacturer

Use By Date

Peel Here

Sterilized using Ethylene Oxide

Equipment includes RF transmitter

Batch Code (Lot Number)

Product Model Number

Serial Number

Part Number

Catalogue Number

Package Contents

Keep Dry

This Way Up

Product Protected by One or More US Patents as listed (International patents & additional patents pending)

Fragile, Handle with Care

Do Not Use if Package is Damaged

WEEE Directive Symbol (Special Disposal Required)

This Device is Not Intended for the Treatment of Bradycardia or Tachycardia

OFF; IPG Programmed Mode as Shipped

This Device is for Use with CVRx System Only

No pacemakers

Programmer Interface Power Status

Programmer Interface USB connection status

This Device is for Use with CVRx IPG Model 2104 and Unipolar Lead Models 1036 and 1037 only and not

compatible with lead models 101x.

8



3

Indications and

Contra-indications

9



INDICATIONS:

The Barostim NEO™ & NEO2™ Systems are indicated for the improvement of symptoms of

heart failure—quality of life, six-minute hall walk and functional status—for patients who

remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA

Class III or Class II (who had a recent history of Class III), have a left ventricular ejection

fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac

Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

CONTRAINDICATIONS:

Patients are contraindicated if they have:

• Been assessed to have bilateral carotid bifurcations located above the level of

the mandible.

• Baroreflex failure or autonomic neuropathy

• Uncontrolled, symptomatic cardiac bradyarrhythmias

• Carotid atherosclerosis that is determined by ultrasound or angiographic

evaluation greater than 50%

• Ulcerative plaques in the carotid artery as determined by ultrasound or

angiographic evaluation.

• Known allergy to silicone or titanium.

10



4

Warnings and

Precautions

11



GENERAL

The safety and effectiveness of Barostim has been demonstrated in clinical trials.

General Warnings

• Only trained physicians may use this system.

• Prescribing physicians should be experienced in the diagnosis and treatment of

hypertension and heart failure and should be familiar with the use of this

system.

• Monitor blood pressure and heart rate during Carotid Sinus Lead placement and

when adjusting stimulation parameters intra-operatively.

• Post-implantation, program the system to avoid the following:

o Heart rate falls below 50 beats per minute (BPM), or

o Systolic pressure falls below 90 mmHg, or

o Diastolic blood pressure falls below 50 mmHg, or

o Problematic adjacent tissue stimulation is noted, or

o Undesirable interaction indicated by monitoring of any other implanted

electrical device (see description below), or

o Any other potentially hazardous patient responses are observed.

• The system may affect the operation of other implanted devices such as cardiac

defibrillators, pacemakers, or neurological stimulation systems. For patients

who currently have an implanted electrical medical device, physicians must

verify compatibility with the implanted device during implantation of the

system as well as whenever settings are changed in either implant interactions

are more likely in devices that contain a sensing function, such as an

implantable cardiac defibrillator or pacemaker. Refer to the manufacturer’s

documentation regarding evaluation of sensing performance in such devices. If

an interaction is observed, the Barostim NEO & NEO2 should be programmed to

reduced therapy output settings in order to eliminate the interaction. If

necessary, change settings in the other implant only if the changes are not

expected to negatively impact its ability to perform its prescribed therapy.

During the implant procedure, if problematic device interactions cannot be

eliminated, the Barostim System should not be implanted.

•

Improper system implantation could result in serious injury or death.

• Do not use Magnetic Resonance Imaging (MRI) on patients implanted with the

system.

• Do not use diathermy therapy including shortwave, microwave, or therapeutic

ultrasound diathermy on patients implanted with the system.

• Patients should be counseled to stay at least 15 cm (6 inches) away from

devices with strong electrical or magnetic fields such as strong magnets,

loudspeaker magnets, Electronic Article Surveillance (EAS) system tag

deactivators, arc welders, induction furnaces, and other similar electrical or

electromechanical devices. This would include not placing items such as

earphones in close proximity to the implanted pulse generator.

12



General Precautions

• The system should be implanted and programmed carefully to avoid stimulation

of tissues near the electrode or in the area of the IPG pocket. Such extraneous

stimulation could involve the following:

o The regional nerves, causing laryngeal irritation, difficulty swallowing, or

dyspnea.

o The cervical musculature, causing intermittent contraction.

o Skeletal muscles, causing intermittent contraction around the IPG pocket.

• Proper sterile technique during implantation should be practiced and aggressive

pre-operative antibiotics are recommended. Infections related to any

implanted device are difficult to treat and may necessitate device

explantation.

• Refer to for precautions related to electromagnetic compatibility.

13



IPG

IPG Warnings

• The IPG is a single-use-only device. Do not re-sterilize or reuse. Reuse of this

product may result in malfunction or adverse events such as

infection or death.

• Do not implant product if the expiration “Use By” date has

been reached.

• Do not implant the IPG if the storage package has been

damaged, compromising the product sterility.

• Persons allergic to silicone, titanium, or polyurethane may

have an allergic reaction to the IPG.

• Patients who manipulate the IPG through the skin may damage or disconnect

the lead from the pulse generator.

IPG Precautions

models 101x.

(50°C).

• This system is compatible with lead models 103x only. Do not use with lead

• Do not store the IPG outside the temperature range of -4° F (-20°C) to 122 F

• Electrocautery may damage the IPG. Position electrocautery as far as possible

from the IPG and items connected to it.

• Do not implant an IPG if the device has been dropped.

• The battery life of the IPG is limited. Patients should be counseled that

replacements will be needed. Recommended Replacement Time (RRT) is

indicated in the programming software and is the date calculated to be within

30 days of the expected End of Service (EOS).

•

IPG operation may cause artifacts in electrocardiogram (ECG) tracings.

• Do not insert a Carotid Sinus Lead in the IPG connector without verifying that

setscrews are sufficiently retracted.

• Prior to tightening the setscrews, make sure that lead is fully inserted into the

IPG connector module.

• Do not ultrasonically clean the IPG.

• Do not incinerate the IPG. Extreme heat could cause the internal battery to

explode. Therefore, it is recommended to remove the IPG from a deceased

patient prior to cremation.

• Therapeutic radiation may damage the IPG. Damage to the IPG due to

therapeutic radiation may not be immediately detectable.

• Lithotripsy procedures can damage the IPG. Position the IPG outside the

ultrasound water bath.

14



• External defibrillation may cause damage to the IPG. During a defibrillation

procedure, space electrodes as far as practical from the IPG. Verify proper IPG

function after defibrillation procedures. In addition, if it is practical, it is

suggested that the IPG be turned off during defibrillation.

• Sterile package seal integrity can be damaged by moisture. Do not expose to

liquids.

•

If any of these 3 situations is observed, a CVRx representative should be

contacted immediately.

o Low lead impedance, less than 300 Ohms, may indicate a short in the lead.

o High lead impedance, greater than 3000 Ohms, may indicate poor lead

connection to IPG or a lead fracture.

o Drastic changes in lead impedance may indicate a problem with a lead.

• Do not place the IPG on a magnetic instrument drape. Doing so may temporarily

stop therapy.

• An additional IPG should be available in the event of compromised sterility or if

damage is induced during surgery.

• End of Service (EOS) is indicated when the IPG battery voltage is too low to

support therapy delivery. Therapy is disabled when EOS is determined. Other

IPG functions, such as lead impedance measurement and telemetry

communication, will still operate after EOS is reached. However, these

functions will eventually cease when the battery voltage is too low to support

these functions.

15



CSL

CSL Warnings

• The Carotid Sinus Lead is a single-use-only

device. Do not re-sterilize or reuse. Reuse of

this product may result in malfunction or

adverse events such as infection or death.

• Do not implant product if expiration “Use By”

date has been reached.

• Do not implant the Carotid Sinus Lead if the

storage package has been damaged, compromising the product sterility.

• This system carries associated risks of lead placement-related trauma to the

carotid sinus and surrounding periarterial tissues, including the regional nerves

and the jugular and hypoglossal veins.

• Persons allergic to silicone, platinum, iridium, or stainless steel may suffer an

allergic reaction to lead placement.

• Only physicians who have appropriate experience in carotid artery surgery and

device-specific training should perform implant of the Carotid Sinus Lead.

• Patients who manipulate the Carotid Sinus Lead through the skin may damage

or disconnect the lead from the IPG resulting in loss of therapy.

• Lead malfunction could cause painful stimulation and/or stimulation of

adjacent tissue.

CSL Precautions

20°C) to 122° F (50C).

liquids.

• Do not store the Carotid Sinus Lead outside the temperature range of -4° F (-

• Sterile package seal integrity can be damaged by moisture. Do not expose to

• Electrocautery at a low but effective power can be used to minimize the

potential of damaging the lead during dissection. Electrocautery at high power

settings may damage the Carotid Sinus Lead.

• Scalpels may damage the Carotid Sinus Lead. Avoid scalpel blade contact with

the lead when using scalpels.

• Do not implant the Carotid Sinus Lead if the device has been dropped.

• Exercise extreme caution in utilizing line-powered equipment in conjunction

with the Carotid Sinus Lead because leakage current could injure the patient.

• Do not use any other lead beside the Carotid Sinus Lead with this system

because such use may damage the IPG or injure the patient.

• An additional Carotid Sinus Lead should be available in the event of

compromised sterility or if damage is induced during surgery.

16



PROGRAMMER

Programmer Warnings

•

components inside the sterile operating

field.

Do not locate any programmer system

Programmer Precautions

•

System should not be sterilized.

The components of the Programmer

• The following are requirements to comply with IEC 60601-1 and IEC 60601-1-1:

o The computer/tablet and power supply should be located

outside the patient environment when the computer is

operated on mains power.

o The system should not be connected to other non-isolated

monitoring equipment or communication networks.

o The operator should not touch the computer/tablet and the

patient simultaneously when the computer/tablet is operated

on mains power.

o The USB cable should be fully inserted into the Programmer Interface USB

receptacle to avoid patient contact with the metal part of the USB

connector.

Note: The patient environment is defined as the area within 1.5m

(approximately 5ft) of the patient.

• Plug the Programmer System directly into an outlet or operate using battery

power. Do not plug the programmer system into a power strip or extension

cord.

• Do not modify the Programmer System (i.e. connect additional equipment via

USB) or install additional software. Doing so may result in reduced

performance, increased emissions, decreased immunity or equivalent

malfunction. Use of a USB Memory Device is acceptable.

• Do not immerse product in water or a safety hazard could arise during use. If

the Programmer System requires cleaning, clean the system components with a

soft cloth dampened with water. Do not allow pooling or ingress of liquid into

the Programmer Interface enclosure.

• Keep the Programmer System in a controlled location to prevent loss or theft.

Intentional misuse of the Programmer System could result in an IPG being

programmed to settings that are not as prescribed.

IMPLANT ADAPTER, IMPLANT TOOL

Warnings

• FOR SINGLE USE ONLY. Do not re-sterilize or reuse. Reuse of this product may

result in malfunction or adverse events such as infection or death.

• Do not use product if “Use Before” date has been reached.

17



Precautions

• Store between -4 F (-20 C) and 122 F (50 C).

• Do not use if the storage package has been damaged, compromising the product

• Sterile package seal integrity can be damaged by moisture. Do not expose to

sterility.

liquids.

18



5

Adverse Events

19

It is anticipated that subjects will be exposed to operative and post-operative risks similar

to related surgical procedures involving the neck and/or a pacemaker implant. These risks

and potential risks of chronic device based Barostim™ may include, but are not limited to:

• Stroke – a neurological deficit lasting more than 24 hours or less than 24 hours

with a brain imaging study showing infarction

• Transient ischemic attack (TIA) – a neurological deficit lasting less than 24

hours without evidence of permanent cerebral infarction

• Systemic embolization – downstream obstruction of a blood vessel by migration

of loosened intravascular plaque or clot

• Surgical or anesthetic complications

•

Infection – the need for antibiotics or possible removal of the system

• Wound Complication – including hematoma (i.e. bruising and/or swelling)

• Arterial damage – including carotid artery rupture or hemorrhage (sudden and

significant blood loss at a site of blood vessel rupture that may require

reoperation or transfusion)

• Pain – an unpleasant sensory experience

• Transient, Temporary, or Permanent Nerve Damage/Stimulation – including

injury to or stimulation of Cranial, Marginal Mandibular, Glossopharyngeal,

Recurrent Laryngeal, Vagus and Hypoglossal Nerves (numbness in head and

neck, facial palsy/paralysis, altered speech, altered sense of taste, respiratory

constriction, stertorous breathing, excessive salivation, dry cough, vomiting

and/or regurgitation, altered sensory and motor function of tongue, altered

sensory function of pharynx and oropharynx, altered sensation in external

auditory canal), stimulation of extravascular tissue (muscle twitching

(fasciculation), pain, tingling, oral sensations)

• Hypotension – a decrease in systolic and diastolic blood pressure below normal

levels that may result in dizziness, fainting, and/or falls

• Hypertensive crisis – uncontrolled rise in blood pressure

• Respiratory – including low oxygen saturation, respiratory distress, shortness of

breath

irregularly

reoperation

• Exacerbation of heart failure

• Cardiac arrhythmias – A condition where the heart beats too fast, too slow, or

• Tissue erosion/IPG migration – movement of device resulting in need for

•

Injury to baroreceptors – an injury that results in baroreflex failure

• Fibrosis – replacement of normal tissue by the ingrowth of fibroblasts and the

deposition of connective tissue

• Allergic Reaction

20



• General injury to user or patient – may be due to surgical procedure, device

use, or interaction with other devices

• Need for reoperation – operation to explant/replace IPG or CSLs due to tissue

damage, infection, and/or device failure

• Secondary operative procedure – An increase in the complexity and risk of

secondary operative procedures of the neck due to scar tissue and the presence

of prosthetic material implanted for this device

• Death

21



6

Clinical Summary

22

CLINICAL SUMMARY

•

•

•

•

•

The Baroreflex Activation Therapy for Heart Failure (BeAT-HF) trial was a prospective,

randomized (1:1), two-arm controlled trial to establish a reasonable assurance of safety

and effectiveness of the Barostim NEO Systems for the reduction of the symptoms of heart

failure in patients. The trial generated data from subjects who met the following key

criteria:

•

Currently NYHA Class II or III heart failure. For NYHA Class II, must have been

NYHA Class III at any point in time within 3 calendar months prior to enrollment or

at time of screening.

Left ventricular ejection fraction ≤ 35% within 45 days prior to randomization.

Heart failure accompanied by BNP≥100 or NT-proBNP ≥ 400 within 45 days prior to

randomization, or a heart failure hospitalization in the past 12 months.

On optimal, stable, Guideline Directed Medical Therapy (GDMT) per country

specific guidelines for the treatment of heart-failure throughout

screening/baseline evaluation and for at least 4 weeks prior to obtaining any post-

consent screening parameters.

Excluding Subjects who:

Received cardiac resynchronization therapy (CRT) within six months of

randomization or is actively receiving CRT.

Currently have a Class I indication for a cardiac resynchronization therapy (CRT)

device according to AHA/ACC/ESC guidelines for the treatment of congestive heart

failure.

The trial enrolled 408 randomized subjects at 92 sites, 91 in the United States (US) and 1

in the United Kingdom (UK).

It was designed as a two-phase trial. The first phase, the Expedited Phase, supports a PMA

under the FDA Breakthrough Devices Program, which is the information included in this

summary. The second phase, the Extended Phase, is ongoing and is intended to collect

post-market long-term information, including morbidity and mortality (M&M) data.

The following endpoints were evaluated at 6 months:

•

•

Safety - Major Adverse Neurological & Cardiac Events, event free rate

Effectiveness – 6 Minute Hall Walk (6MHW), Minnesota Living with Heart Failure

(QoL) and NT-proBNP.

Subjects were randomized in a 1:1 ratio to receive Baroreflex Activation Therapy (BAT)

with an implanted Barostim System in addition to medical management (BAT + MM) or to

receive medical management (MM) alone (no device implant). After evaluating the pre-

planned Expedited Phase initial data review in early October 2018, a large, important and

clinically relevant population was identified. This subgroup population is characterized by

having NYHA Class III or II (recent history of Class III) heart failure, left ventricular

ejection fraction ≤ 35% and baseline NT-proBNP < 1600 pg/ml at the time of baseline.

This subgroup, referred to as the Intended Use Population, is the focus of the PMA.

The Intended Use Population for the Expedited Phase analysis of the 6-month efficacy

endpoints, includes all subjects randomized with a baseline NT-proBNP<1600 that have

complete baseline and six-month data for MLWHF QOL, 6MHW and/or NT-proBNP. The

23



evaluation of the MANCE free rate includes all subjects in the BAT + MM arm in the

Intended Use Population that have an attempted implant.

Within the Intended Use Population supporting the Expedited Phase, there are two cohorts

of data. Data that was previously analyzed in the original PMA dated December 14, 2018,

called the Initial Cohort data, and data that had not been previously unblinded and

analyzed and also is included here, called the Second Cohort data that was collected

through April 22, 2019. See Table 1 below for a breakdown of the intended use

populations that were used for the safety and effectiveness analyses.

Table 1: Analysis Populations for the Expedited Phase - Intended Use

BAT +

Medical

Management

Medical

Management

Total

Description

Expedited Phase Population - Intended Use

Expedited Phase Six Month Efficacy Analysis Population -

Intended Use

Not in Expedited Phase Six Month Efficacy Analysis

Population - Intended Use

No Implant Attempt

Died / LVAD / Heart Transplant prior to 6 month visit

Withdrew / LTFU prior to 6 month visit

Missed 6 month visit

Expedited Phase Safety Analysis Population - Intended Use

125

Not in Expedited Phase Safety Analysis Population -

Intended Use

No Implant Attempt

Total Randomized - Intended Use

130

130

120

10

5

1

2

2

5

5

134

125

N/A

9

5

0

4

N/A

N/A

N/A

134

264

245

19

5

6

2

6

5

5

125

264

The demographics of the study Intended Use Population are typical for a reduced ejection

fraction heart failure study performed in the US and UK. Baseline demographics for

Expedited Phase Intended Use Population subjects are in Table 2 below. Demographics

between the two randomized arms were balanced. Approximately 35% had a history of

atrial fibrillation, 24% chronic kidney disease and 47% Type II diabetes. Almost all subjects

(93 to 95%) are NYHA Class III at baseline with an average LVEF of 27% for BAT +MM and

28% for MM.

Table 2: Demographics at Baseline - Intended Use

BAT + Medical Management

Medical Management

Variable

Range P-value

Mean ± SD

or N (%)

Range

3 (2.3%)

24 (18.5%)

97 (74.6%)

N/A

N/A

N/A

Mean ± SD

or N (%)

2 (1.5%)

20 (14.9%)

96 (71.6%)

N

134

134

134

N

130

130

130

N/A

N/A

N/A

0.680

0.510

0.677

24

Race

Asian

White

Black or African American

N

130

130

130

130

130

130

130

130

130

130

130

130

130

BAT + Medical Management

Medical Management

Variable

Range

N

Range P-value

Mean ± SD

or N (%)

Mean ± SD

or N (%)

6 (4.6%)

24 (18.5%)

N/A

N/A

134

134

16 (11.9%)

29 (21.6%)

N/A

N/A

0.044

0.542

Age at Screening (years)

62 ± 11

27 - 92

134

63 ± 10

35 - 83

0.614

Other/Unknown

Female

BMI (kg/m2)

SBP (mmHg)

DBP (mmHg)

HR (bpm)

LVEF (%)

NYHA: Class III

6 Minute Walk (m)

QOL

eGFR

LBBB

Core Lab NT-proBNP (pg/mL)*

130 731 (475, 1021) 72 - 1582 134 765 (479, 1052) 54 - 1587

0.786

31 ± 5

17 - 40

134

31 ± 5

20 - 43

0.699

120 ± 17

80 - 183

134

121 ± 16

90 - 179

0.385

73 ± 10

48 - 107

134

73 ± 10

50 - 101

0.618

75 ± 10

56 - 99

134

75 ± 11

40 - 100

0.864

27 ± 7

10 - 35

134

28 ± 6

12 - 35

0.192

130

121 (93.1%)

N/A

134

127 (94.8%)

N/A

0.614

316 ± 68

156 - 475 134

294 ± 73

60 - 442

0.015

53 ± 24

3 - 100

134

52 ± 24

6 - 105

0.800

130

63.6 ± 16.8

32 - 113

134

61.9 ± 19.5

25 - 144

0.430

QRS Interval

130

108.9 ± 17.6

49 - 168

134

110.5 ± 25.6

23 - 241

0.545

At Least One HF Hospitalization

Number of HF Hospitalizations

3 (2.3%)

54 (41.5%)

0.6 ± 1.0

134

134

134

1 (0.7%)

68 (50.7%)

0.7 ± 0.8

Enrolled under Rev. D of Protocol

130

110 (84.6%)

134

107 (79.9%)

Origin of Subject: Advertising

130

18 (13.8%)

134

21 (15.7%)

N/A

N/A

0 - 6

N/A

N/A

N/A

N/A

0 - 4

N/A

N/A

0.365

0.140

0.815

0.338

0.730

*Results reported as median (IQR).

As shown in Table 3, most of the subjects had coronary artery disease (65%) and/or a prior

MI (59%). Approximately 35% had a history of atrial fibrillation, 24% chronic kidney disease

and 47% Type II diabetes.

Table 3: Medical History Reported Comorbidities - Intended Use

BAT + Medical

Management

Medical Management

Mean ± SD

or N (%)

Rang

e

Mean ± SD

or N (%)

Rang

e

P-value

Variable

Coronary Heart Disease

N

Coronary Artery Disease

130 80 (61.5%)

N/A

134

92 (68.7%)

N/A

0.246

Myocardial Infarction

130 68 (52.3%)

N/A

134

86 (64.2%)

N/A

0.061

CABG

PCI

130 23 (17.7%)

N/A

134

39 (29.1%)

N/A

0.030

130 53 (40.8%)

N/A

134

62 (46.3%)

N/A

0.387

N

Cardiac Arrhythmia

Bradycardia

130 13 (10.0%)

N/A

134

14 (10.4%)

N/A

1.000

25



Variable

BAT + Medical

Management

Medical Management

Mean ± SD

or N (%)

Rang

e

N

Mean ± SD

or N (%)

Rang

e

N

P-value

Tachycardia

130 43 (33.1%)

N/A

134

46 (34.3%)

N/A

0.897

Atrial Fibrillation

130 38 (29.2%)

N/A

134

57 (42.5%)

N/A

0.029

Stroke or TIA

130 24 (18.5%)

N/A

134

30 (22.4%)

N/A

0.449

Chronic Kidney Disease

130 31 (23.8%)

N/A

134

33 (24.6%)

N/A

0.887

130

0 (0.0%)

N/A

134

2 (1.5%)

N/A

0.498

130 58 (44.6%)

N/A

134

68 (50.7%)

N/A

0.327

Diabetes

Type I

Type II

Baseline heart failure treatments are shown in Table 4 below. Most of the subjects (87%)

were on an ACE-I/ARB or ARNI, 95% on a beta blocker and 92% on a diuretic.

Approximately 78% had an ICD and <5% had another cardiac device (6 CardioMems, 3

Lifevest and 1 loop recorder).

Table 4: Heart Failure Treatments at Baseline - Intended Use

BAT + Medical

Management

Mean ± SD

or N (%)

N

Medical Management

Mean ± SD

or N (%)

Treatment

Range

N

Range P-value

Number of Meds

130

3.9 ± 1.2

1 - 8

134

4.1 ± 1.4

1 - 8

0.228

% recommended dose

73

29.3 ± 25.5

3 - 100

79

27.6 ± 24.3

6 - 100

0.672

130

75 (57.7%)

N/A

134

79 (59.0%)

N/A

0.901

% recommended dose

124

29.8 ± 26.4

6 - 125

126

28.1 ± 27.7

3 - 150

0.614

130

124 (95.4%)

N/A

134

127 (94.8%)

N/A

1.000

130

110 (84.6%)

N/A

134

117 (87.3%)

N/A

0.596

130

3 (2.3%)

N/A

134

6 (4.5%)

N/A

0.501

% recommended dose

63

55.6 ± 36.0

25 - 300

54

59.3 ± 54.1

25 - 400

0.660

130

63 (48.5%)

N/A

134

56 (41.8%)

N/A

0.322

% recommended dose

41

41.5 ± 20.6

25 - 100

35

42.9 ± 28.6

13 - 100

0.806

130

41 (31.5%)

N/A

134

35 (26.1%)

N/A

0.344

ACE/ARB or ARNI Use

130

115 (88.5%)

134

113 (84.3%)

130

101 (77.7%)

134

106 (79.1%)

N/A

N/A

N/A

N/A

0.372

0.881

26

ACE-I/ARB

Use

Beta-Blocker

Use

Diuretic

Use

Ivabradine

Use

MRA

Use

ARNI

Use

ICD



Medical Management

BAT + Medical

Management

Mean ± SD

or N (%)

N

130

130

130

2 (1.5%)

3 (2.3%)

6 (4.6%)

Range

N

N/A

N/A

N/A

134

134

134

Mean ± SD

or N (%)

1 (0.7%)

4 (3.0%)

4 (3.0%)

Range P-value

N/A

N/A

N/A

0.618

1.000

0.536

Treatment

Pacemaker (non-ICD)

CRT

Other cardiac device (e.g.,

CardioMEMS)

Safety Results

The system or procedure related Major Adverse Neurological and Cardiovascular Events

(MANCE) endpoint includes all events that occur within 6-months post implant. The

analysis includes the BAT + MM in the Intended Use Population who had an implant

attempted (n=125).

As shown in Table 5 below, the MANCE-free rate for the Intended Use Population is 96.8%

(121/125) with a lower bound one-sided 95% confidence level of 92.8% (p value <0.001).

As the lower bound is greater than 85%, the safety endpoint has been met in the Intended

Use Population.

Table 5: System or Procedure Related MANCE-Free Rate in BAT

+ Medical Management - Intended Use

Total

Number of

Subjects

Number of

Subjects

MANCE-Free

MANCE-Free

Rate

One-Sided

95% Lower

Bound

P-

value

MANCE Event-Free

125

121

96.8%

92.8%

<.001

The four MANCE components are shown in Table 6 below. There were 2 infections

requirement explant, 1 acute decompensated heart failure event and 1 stroke.

Table 6: System or Procedure Related MANCE Events

in BAT + Medical Management - Intended Use

Event

CV Death

Stroke

Cardiac Arrest

Acute MI

Acute Decompensated HF

Implanted Subjects

(N=125)

Number

of Events

Number

of

Subjects

Event

Rate

0

1

0

0

1

0

1

0

0

1

0.0%

0.8%

0.0%

0.0%

0.8%

27



Event

Implanted Subjects

(N=125)

Number

of Events

Number

of

Subjects

Event

Rate

Hypertensive Crisis

Severe Complication of HF Treatment

Systemic and Pulmonary Thromboembolism

Infection Requiring Explant

Cranial Nerve Damage

Non-Elective Major Restorative Procedures

Total

0

0

0

2

0

0

4

0

0

0

2

0

0

4

0.0%

0.0%

0.0%

1.6%

0.0%

0.0%

3.2%

Out of the 125 subjects implanted in the Intended Use Population, 9 subjects experienced

12 system- or procedure-related complications within six months of implant. The

complication-free rate in the Intended Use Population is 92.8%. A listing of the system or

procedure related complications is shown in Table 7 below.

28

Table 7: Six Month System or Procedure Related Complications

in BAT + Medical Management - Intended Use

29



Event

Implanted Subjects

(N=125)

Number of

Events

Number of

Subjects Event Rate

Heart Failure, Acute Decompensated

Heart Failure

Muscle and Bone

Nerve Damage/Stimulation, Cranial Nerve

Stimulation

Other Nerve, Hoarseness

Respiratory, Other Respiratory, Acute

hypercarbic respiratory failure

Respiratory, Pneumonia

Stroke (CVA), Ischemic

Surgical or Anesthetic Complications,

Infection at Implant Site (No Explant)

Surgical or Anesthetic Complications,

Infection at Implant Site Requiring

Explanation

Surgical or Anesthetic Complications,

Other Surgical Complication, prolonged

intubation

Thromboembolism, Systemic

Heart Failure, Acute Decompensated Heart

Failure

Muscle and Bone

Nerve Damage/Stimulation, Cranial Nerve

Stimulation

Other Nerve, Hoarseness

Respiratory, Other Respiratory, Acute

hypercarbic respiratory failure

Respiratory, Pneumonia

Severe Complications of Heart Failure

Treatment

Stroke (CVA), Ischemic

1

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

1

1

1

12

1

1

1

1

1

1

1

1

2

1

1

9

1

1

1

1

1

1

1

1

0.8%

0.8%

0.8%

0.8%

0.8%

0.8%

0.8%

0.8%

1.6%

0.8%

0.8%

7.2%

0.8%

0.8%

0.8%

0.8%

0.8%

0.8%

0.8%

0.8%

Total

Event

Implanted Subjects

(N=125)

Number of

Events

Number of

Subjects Event Rate

30



Event

Implanted Subjects

(N=125)

Number of

Events

Number of

Subjects Event Rate

Surgical or Anesthetic Complications,

Infection at Implant Site (No Explant)

Surgical or Anesthetic Complications,

Infection at Implant Site Requiring

Explanation

Surgical or Anesthetic Complications, Other

Surgical Complication, prolonged intubation

Thromboembolism, Systemic

1

1

1

1

12

1

1

1

1

9

0.8%

0.8%

0.8%

0.8%

7.2%

Total

During the study, there were three contralateral ICD implants that had interactions with

the NEO IPG. All were noted to have been addressed by reducing the programmed therapy

settings for the NEO IPG.

ADDITIONAL SAFETY INFORMATION

Additional safety information using the data cutoff from the April 30, 2019, Executive

Summary (PMA) Report includes the analysis shown in 8 below. This table was reported in

the supplementary material of the peer reviewed Zile et al, JACC 2020 article, Appendix

Table 13: Cardiovascular Serious Events.1 In the report the average follow-up time in the

Intended Use Population for these cardiovascular events was 14.5 months, with over 313

total years of follow-up.

8 demonstrates that BAT appears to reduce the rate of cardiovascular serious events

compared to control in the Intended Use Population 2, 3

Table 8: Cardiovascular Serious Events in Intended Use Subjects

1 Zile et al, Appendix Table 13: Cardiovascular Serious Events, Supplemental Information to

"Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction." J

Am Coll Cardiol 76(1): 1-13, 2020.

2 Zile et al. Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection

Fraction. J Am Coll Cardiol, 2020, 76(1): 1-13.

3 Supplemental Information to "Baroreflex Activation Therapy in Patients With Heart Failure With

Reduced Ejection Fraction." J Am Coll Cardiol 2020, 76(1): 1-13.

31



BAT

(N=125)

Control

(N=134)

Number

of Events

(#

subjects)

Event Rate

per patient

year of

follow-up

Number

of Events

(#

subjects)

Event Rate

per

patient

year of

follow-up

Relative

Reduction in

Event Rate

(95% CI)

p-value

8 (6)

0.054

18 (12)

0.109

0.50 (-0.14, 0.78) 0.100

Serious Adverse

Event

Cardiac

Arrhythmias/Cardiac

Arrest

Hypotension/Syncope 2 (2)

6 (4)

0.036

0.63 (-0.85, 0.92) 0.226

MI/Angina

5 (4)

10 (10)

0.060

0.44 (-0.63, 0.81) 0.288

0.014

0.034

Total

15 (11)

0.101

34 (22)

0.206

0.51 (0.10,

0.73)

0.023

There were no unanticipated adverse events reported in the study.

Effectiveness Results

Six-minute hall walk (6MHW) performed according to a standard protocol, Minnesota Living

With Heart Failure Quality of Life (MLWHF QOL) Questionnaire data, and a blinded core lab

evaluated NT-proBNP were collected at the baseline visit and during follow-up at 6-

months. The 6 month results are reported below in the Expedited Phase Efficacy Analysis

for the Intended Use Population subjects.

Within the population supporting the Expedited Phase, there are two cohorts of data.

Data that was previously analyzed in the original PMA Clinical Report, dated December 14,

2018, called the initial data, and data that has not been previously unblinded and

analyzed and is included here, called the second data, that was collected through April

22, 2019. Unless otherwise specified, the data presented is the Initial Cohort and Second

Cohort.

Table 8 below shows the six-minute walk differences between the arms in the Second and

Initial Cohorts for the Intended Use Population. The results showed a consistent and

clinically meaningful and statistically significant improvement between the arms for the

Initial, the Second and Combined Cohorts.

Table 9: Change in Six Minute Walk Distance at 6 Months – Intended Use

Second, Initial and Combined Cohorts

BAT + Medical

Management

Medical

Management

Difference*

Cohort

Initial

N

69

Mean±SD

(95% CI)

49.0 ± 71.6

(31.8, 66.2)

N

80

Mean±SD

(95% CI)

Δ Means

(95% CI)

-11.9 ± 92.8

(-32.5, 8.8)

65.4

(38.5, 92.3)

p-

value

<0.001

32



BAT + Medical

Management

Medical

Management

Difference*

Cohort

Second

N

49

Combined

118

Mean±SD

(95% CI)

48.1 ± 58.7

(31.2, 64.9)

48.6 ± 66.3

(36.5, 60.7)

N

40

Mean±SD

(95% CI)

Δ Means

(95% CI)

0.1 ± 79.2

(-25.3, 25.4)

49.8

(21.8, 77.9)

p-

value

<0.001

120

-7.9 ± 88.4

(-23.9, 8.1)

60.1

(40.3, 79.9)

<0.001

*The difference is evaluated based on an ANCOVA model adjusting for the baseline value.

Table 9 below shows the quality of life differences between the arms in the Second and

Initial Cohorts for the Intended Use Population. The results showed a consistent and

clinically meaningful and statistically significant improvement between the arms for the

Initial, the Second and Combined Cohorts.

Table 10: Change in Quality of Life at 6 Months - Intended Use

Second, Initial and Combined Cohorts

BAT + Medical

Management

Medical

Management

Difference*

N

70

50

Mean±SD

(95% CI)

-21.3 ± 25.2

(-27.3, -15.2)

-19.9 ± 25.9

(-27.2, -12.5)

N

83

42

Mean±SD

(95% CI)

Δ Means

(95% CI)

-9.0 ± 19.6

(-13.3, -4.7)

-12.1

(-18.7, -5.6)

p-

value

<0.001

-0.8 ± 20.0

(-7.0, 5.5)

-17.8

(-26.1, -9.4)

<0.001

Cohort

Initial

Second

Combined

120

-20.7 ± 25.4

(-25.3, -16.1)

125

-6.2 ± 20.1

(-9.8, -2.7)

-14.1

(-19.2, -8.9)

<0.001

*The difference is evaluated based on an ANCOVA model adjusting for the baseline value.

Table 10 below shows the Log10 NT-proBNP differences between the arms in the Initial,

Second and Combined data Cohorts for the Intended Use Population. The results showed

and clinically meaningful and statistically significant improvement between the arms for

the Second Cohort, validating the strong signal seen in the Initial Cohort.

33

Table 11: Change in Log10 NT-proBNP at 6 Months – Intended Use

Second, Initial and Combined Cohorts

Cohort

Initial

BAT + Medical

Management

Medical

Management

Difference*

N

67

Mean±SD

(95% CI)**

-16.7% ± 0.3

(-30.2%, -0.5%)

N

82

Mean±SD

(95% CI)**

Δ Means

(95% CI)**

-17.9%

(-34.3%, 2.7%)

p-

value

0.08

Second

53

-26.4% ± 0.4

(-43.7%, -3.9%)

41

-36.5%

(-55.2%, -10.1%)

0.01

1.9% ± 0.3

(-12.4%,

18.5%)

6.4% ± 0.3

(-15.9%,

34.5%)

Combined

120

-21.1% ± 0.4

(-32.3%, -8.2%)

123

3.3% ± 0.3

(-8.9%, 17.2%)

-24.6%

(-37.6%, -8.7%)

0.004

*The difference is evaluated based on an ANCOVA model adjusting for the baseline value.

**Results modeled parametrically on the log10 scale. Results are converted to percent change from baseline usi

ng [10**(log10(a) - log10(b)) - 1 = (a-b)/b]. Standard deviation is on log10 scale.

Table 11 below shows the New York Heart Association (NYHA) Class functional status

differences between the arms in the Combined (Initial and Second Cohorts) of the

Intended Use Population.

Table 12: Change in NYHA Class at 6 Months– Intended Use, Combined Cohort

BAT + Medical

Management

Medical

Management

Change in

NYHA

N

N (%)

N

N (%)

P-value

Improved 2 Classes 120

16 (13.3%)

125

3 (2.4%)

<.001

Improved 1 Class

No Change

Deteriorated

62 (51.7%)

42 (35.0%)

0 (0.0%)

36 (28.8%)

84 (67.2%)

2 (1.6%)

34



Adding New Class of Heart Failure Drugs

Table 13 shows the data reported in Appendix Table 12, Subjects Adding New Class

of Heart Failure Drugs by Six Months in Cohort D Control (n=125). in the JACC 2020

article supplementary material.

During the 6-month follow-up there was a significant difference in medical

management between the 2 arms, with a higher number of medications added in

the control group (Supplemental Table 12, Zile et al).1 Patients in the control

group were more likely to have a new class of drugs added compared to BAT, with

BAT still providing benefit and meeting the endpoints for 6MHW, QoL, and NT-

proBNP.

Table 13: Addition of New Class of Heart Failure Drugs4 in Intended Use Subjects

Control

(N=125)

BAT (N=120) Difference

Any Medication Class

36 (28.8%)

21 (17.5%)

(95% CI)

11.3% (0.8,

21.8)

P-value *

0.049

ACE / ARB

5 (4.0%)

4 (3.3%)

0.7% (-4.0, 5.4) 1.000

ARNI (Sacubitril/Valsartan)

20 (16.0%)

5 (4.2%)

11.8% (4.5,

19.2)

0.003

Beta Blocker

4 (3.2%)

3 (2.5%)

0.7% (-3.5, 4.9) 1.000

Digitalis

Diuretic

3 (2.4%)

0 (0.0%)

2.4% (-0.3, 5.1) 0.247

3 (2.4%)

5 (4.2%)

Ivabradine

1 (0.8%)

3 (2.5%)

MRA

4 (3.2%)

3 (2.5%)

0.7% (-3.5, 4.9) 1.000

Other HF Meds

9 (7.2%)

2 (1.7%)

5.5% (0.5, 10.6) 0.060

* p-value from 2-sided Fisher's exact test

-1.8% (-6.2,

2.7)

-1.7% (-4.9,

1.5)

0.493

0.362

4 Zile et al, Appendix Table 12: Subjects Adding New Class of Heart Failure Drugs by Six Months in Cohort D

Control (N=125), Supplemental Information to "Baroreflex Activation Therapy in Patients With Heart

Failure With Reduced Ejection Fraction." J Am Coll Cardiol 76(1): 1-13, 2020. (Error! Reference

source not found.)

35



Discussion and Conclusion

In the Intended Use Population, safety was demonstrated in the BeAT-HF trial in the 125

implanted subjects with a system- or procedure-related MANCE-free rate of 96.8%. There

were four MANCE events related to the system and/or the procedure of which all

recovered, three with no residual effect. There were no deaths in the BAT + MM

associated with either system or the procedure. There were no unanticipated adverse

events.

For the three effectiveness endpoints in the Intended Use Population, the BAT + MM arm

consistently showed significant improvement from baseline to six months, while the

Medical Management arm showed virtually no change. In the Second cohort, the

difference between the device was +50 meters (p<0.001) in 6MHW, -18 points in MLWHF

QOL (p<0.001) and -37% for NT-proBNP (p=0.01). These improvements were clinically

significant within the BAT + MM arm, as well as between the arms. These effectiveness

results were consistent across the Initial and the Second cohorts.

In the Expedited Phase Intended Use Population analysis for the PMA, the MANCE safety

endpoint and the two symptomatic endpoints (6MHW and QOL) were statistically and

clinically significant. Additionally, as reported, the blinded core lab evaluated NT-proBNP

provided objective evidence of device effect as validated by the Second Cohort’s

statistically significant results. The results of the BeAT-HF trial demonstrate compelling

evidence that the Barostim NEO is both safe and effective and is ready for commercial use

for the improvement of the symptoms of heart failure in patients who remain symptomatic

despite treatment with guideline-directed therapy, have a left ventricular ejection

fraction ≤ 35% and a NT-proBNP <1600 pg/ml, excluding patients indicated for Cardiac

Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

36



7

Physician and

Training Experience

37

TRAINING REQUIREMENTS

CVRx requires training for physicians who wish to use this system.

38



8

Emergency

Personnel

Information

39

RADIOPAQUE IDENTIFIER

The IPGs have a unique radiopaque identifier located in the connector portion of the

device. This allows medical personnel to use X-ray to identify information about the

implanted medical device. An example of an IPG radiopaque identifier is shown along with

a description of the identifying characters.

The radiopaque identifier indicates the following.

CVRx® as the company for which the IPG was

•

manufactured.

•

2102, A6 = Model 2104).

•

(example: 19=2019).

The model of the IPG (example: A5 = Model

The year in which the IPG was manufactured

The device may be implanted on patient’s right or left

side. This illustration shows the device implanted on

the patient’s right side.

ECG ARTIFACT

Artifacts in ECG tracings may be seen when the IPG is active.

TEMPORARILY INHIBITING THE IPG OUTPUT

Standard doughnut magnets that are distributed for use with pacemakers and ICDs are

readily available in both cardiology clinics and hospitals. These magnets may be used to

temporarily inhibit the IPG output when the output is active. Position the center hole of

the magnet over the area of the IPG connector block and leave in place to inhibit output.

Remove the magnet to resume prescribed IPG therapy.

40



9

Warranty

&

Disclaimer of

Warranty

41



IMPORTANT NOTICE – LIMITED WARRANTY

This Limited Warranty is provided by CVRx, Inc. 9201 West Broadway Avenue, Suite 650,

Minneapolis, MN 55445.

This LIMITED WARRANTY assures the patient who receives Barostim NEO & NEO2 (referred

to as the “Product”) that, should the Product not function to specification for any reason

within one year after implant (“Warranty Period”), CVRx® will provide a replacement at no

charge.

All Warnings contained in the Product labeling are an integral part of this LIMITED

WARRANTY.

To qualify for the LIMITED WARRANTY, these conditions must be met:

The Product must be used prior to its “Use By” date.

The Product must not have been repaired or altered outside of CVRx’s control in any way

which, in the judgment of CVRx®, affects its stability and reliability. The Product must

not have been subjected to misuse, abuse or accident.

The Product must be returned to CVRx® within 30 days of discovery of the potential non-

conformity leading to a claim under this LIMITED WARRANTY. All returned Product shall

be the property of CVRx.

CVRx® is not responsible for any incidental or consequential damages, including but not

limited to medical fees, based upon any use, defect, or failure of the Product, whether

the claim is based on warranty, contract, tort, or otherwise.

This Limited Warranty is made only to the patient who receives the Product. As to all

others, CVRx® makes no warranty, express or implied, including but not limited to, any

implied warranty of merchantability or fitness for a particular purpose, whether arising

from statute, common law, custom or otherwise. No such express or implied warranty to

the patient shall extend beyond the period of one year. This Limited Warranty shall be

the exclusive remedy available to any person.

The exclusions and limitations set out above are not intended to and should not be

construed so as to contravene any mandatory provisions of applicable law. If any part or

term of this LIMITED WARRANTY is held by a court of competent jurisdiction to be illegal,

unenforceable, or in conflict with applicable law, the validity of the remaining portions of

this LIMITED WARRANTY shall not be affected and all rights and obligations shall be

construed and enforced as if this Disclaimer of Warranty did not contain the particular

part or term held to be invalid.

No person has any authority to bind CVRx® to any representation, condition or warranty

except this Limited Warranty.

42



10

Specifications

43

IMPLANTABLE PULSE GENERATOR

Specification

Mass

Height

Width

Thickness

Volume

Connectors

Materials

2104

55 grams

68 mm

50 mm

14 mm

< 36 CC

2102

60 grams

72 mm

50 mm

14 mm

< 40 CC

No sensing

Unipolar Stimulation

1.5 mm lead pin bore diameter

3.48 mm lead shaft bore diameter

Titanium Can

Polyurethane Header

Silicone Seals

Stainless Steel Setscrews

Leads

Use only CVRx® lead Models 103x

Materials in Port Plug

Port Plug not supplied nor

required

One port plug provided:

Comprised of a Stainless

Steel shaft and silicone body

Battery

1 carbon monofluoride and silver vanadium oxide cell

7.50 Ah Theoretical Capacity

Current Consumption

and Nominal Projected

Life

Disposal of Product

Current Consumption depends on parameter settings. See

Section Implantable Pulse Generator for details.

Please contact CVRx® representative to return product to

CVRx. Product should not be disposed of in trash.

Operational

Temperature Range

Storage/Shipping

Temperature Range

IPG Therapy Settings as

Shipped

10° C to 45° C

-20° C to 50° C

Therapy Off

44

Implantable Pulse Generator Parameters

Parameter

Description

Units

Programmable Values

Therapy

Schedule

From/To Times for Therapy (N) or

Therapy Off

HH:MM

Up to 3 entries allowed

Any time during the day

In 15 minute steps

The amplitude of each applied pulse.

milliamp

Pulse

Amplitude

for Therapy

(N)

Pulse Width

for Therapy

(N)

Therapy

Frequency

for Therapy

(N)

Burst

1.0 to 20.0

15 to 500

10 to 100

Not checked /

Checked

µs

PPS

N/A

The width of each applied pulse.

The frequency of applied pulses except

during the Rest portion of the Burst

Interval.

Not Checked = therapy pulses are applied

throughout the burst cycle in a

continuous manner

Checked = pulses are applied in a cycle

of active and rest periods.

burst cycle during which the Therapy

Frequency is delivered.

NOTE: This parameter is not shown if

Burst is not checked.

The total length of the burst cycle

including the active portion and the rest

portion.

NOTE: This parameter is not shown if

Burst is not checked.

Burst Duration The length of the active portion of the

milliseconds

50 to 1950

Burst Interval

milliseconds

100 to 2000

Implantable Pulse Generator Longevity

The battery lifetime of the IPG is dependent on device therapy settings. Assuming 825 Ohm lead

impedance the following table indicates the resulting longevity based on different therapy settings.

For these calculations, a single 24-hour therapy was assumed.

Pulse

Amplitude

(mA)

Pulse Width

(us)

Therapy

Frequency

(Hz)

4.2

5.6

7.2

*8.0

125

125

125

250

40

40

40

40

*Worst case conditions

2104 Device

Longevity

(Months)

2102 Device

Longevity

(Months)

100

74

55

25

79

60

44

28

45

LEAD (MODELS 1036 AND 1037)

Specification

Length

Compatibility

Connector

Connector Type

Pin

Ring

Lead Body

Electrodes

Value (Nominal)

Model 1036: 40 cm

Model 1037: 50 cm

Compatible with CVRx® Barostim NEO & NEO2™

Compatible with CVRx® Barostim NEO IPG

Active: Diameter = 1.41 mm, Active Length = 5.18 mm

Inactive: Diameter = 2.67 mm, Active Length = 4.06 mm

Connector (Pin to Ring) Length

14.22 mm (including active ring length)

Pin/Ring Material

Stainless Steel

Seal/ Insulating Material

Silicone Rubber

Conductor Material

Cobalt-Nickel-Chromium-Molybdenum Alloy with Silver Core

Lead Body Insulation Material

Silicone Rubber

Electrode Material

Platinum Iridium with Iridium Oxide Coating

Electrode Backer Material

Silicone Rubber

Disposal of Product

Please contact CVRx® representative to return product to

CVRx. Product should not be disposed of in trash.

Storage/Shipping Temperature

Range

-20° C to 50° C

46



CAROTID SINUS LEAD REPAIR KIT

Specification

Value (Nominal)

Length (as provided)

28 cm

Compatible with CVRx® Rheos, Barostim NEO & NEO2, and

Barostim™ Legacy Systems

Compatibility

Connector

Pin

Ring

Connector Type

Bipolar, compatible with, Neo, NEO2 and Legacy IPG

Diameter = 1.41 mm, Active Length = 5.18 mm

Diameter = 2.67 mm, Active Length = 4.06 mm

Connector (Pin to Ring) Length

14.22 mm (including active ring length)

Pin/Ring Material

Stainless Steel

Seal/ Insulating Material

Silicone Rubber

Lead Body

Conductor Material

Cobalt-Nickel-Chromium-Molybdenum Alloy with Silver Core

Lead Body Insulation Material

Silicone Rubber

Disposal of Product

Please contact CVRx® representative to return product to

CVRx. Product should not be disposed of in trash.

47



PROGRAMMER SYSTEM

Specification

Value

Operating temperature

9010: 50° F to 95° F (10° C to 35° C)

9020: 50° F to 95° F (10° C to 35° C)

If equipment has been stored at temperature extremes, then

the equipment should be placed at operating temperature

for at least 1 hour prior to use.

Atmospheric pressure

525 mmHg to 760 mmHg (700 hPa to 1010 hPa)(10.2 psia to

14.7psia)

Vibration

0.5G, 10 to 500 Hz, 0.5 octave/min sweep rate

Storage/shipping temperature

9010: -4o F to 140o F (-20o C to 60o C)

9020: 32° F to 95° F (0° C to 35° C)

Storage/shipping humidity

5% to 90% relative humidity

Network Connectivity

Connection to a local network via Wi-Fi or ethernet

connection is disabled. Connection to a secure network for

the purposes of updating software and retrieving session

information is provided through a cellular modem. There

are no user features related to network connectivity.

CVRx® complies with data privacy regulations in the regions

where the system is sold.

Data Privacy

48



Programmer System Components

Programmer System

IEC60601-1-2 System Clause

Component

Specification

Value

Programmer Interface

Power Supply Input

From computer/tablet

Additional equipment connected to medical

electrical equipment must comply with the

respective IEC or ISO standards (e.g., IEC 62368-1

for information technology equipment).

Furthermore, all configurations shall comply with

the requirements for medical electrical systems

(see clause 16 of the 3rd Ed. Of IEC 60601-1).

Anybody connecting additional equipment to

medical electrical equipment configures a medical

system and is therefore responsible that the system

complies with the requirements for medical

electrical systems. Attention is drawn to the fact

that local laws take priority over the above-

mentioned requirements. If in doubt, consult your

local representative or the technical service

department.

The Programmer Interface is suitable for use in the

patient environment.

There are no Installation, Commissioning or

Modifications required for the proper use of the

Programmer System. No installation measurements

are required. Regular maintenance is also not

required.

Inspect the Programmer Interface, computer/tablet

and cables prior to each use. Notify CVRx® or your

CVRx representative of any items that need

replacement.

Programmer Interface

IEC60601-1 System Clause

System Installation and Maintenance

Computer/Tablet

Specification

Value

Safety and EMC Requirements

EN 60950-1

EN IEC 62368-1

UL 60950-1

EN 55022

EN 55024

FCC Part 15 Class B emissions

49



Programmer Miscellaneous Information

Description

Information

Type of protection against electric

shock

The Programmer Interface is not mains powered

equipment.

Degree of protection against electric

shock

The Programmer Interface meets IEC 60601-1 touch

current requirements.

Degree of protection against the

ingress of water

Ordinary

Methods of sterilization or disinfecting

Cannot be sterilized.

Information regarding electromagnetic

or other interference and advice

regarding avoidance as necessary.

Do not use in the proximity of equipment that generates

electromagnetic interference (EMI). EMI may cause a

disruption in programmer function. Examples are cell

phones, x-ray equipment, and other monitoring

equipment.

Accessories or materials used with

equipment that may affect safety.

USB cable to connect computer/tablet to Programmer

Interface

Cleaning and maintenance, with

frequency

If the Programmer System requires cleaning, clean the

system components with a soft cloth dampened with

water. Do not allow pooling or ingress of liquid into the

Programmer Interface enclosure.

No preventative maintenance is required.

Do not use programmer system if programming unit or

cables appear damaged.

There are no serviceable items.

Please contact CVRx® representative to return product

for service or replacement.

Unplug power cord to isolate equipment from supply

mains.

Equipment Supply Disconnect

Manufacturer Name

CVRx, Inc.

Model #(s)

Power Supply

Programmer System: Model 9010

Programmer System Model 9020

9010:

Input Voltage: 100-240V

Input Current: 0.6A

Input Frequency: 50/60Hz

Output Voltage: 20V

Output Current: 3.25A

Output Power: 65W

9020:

Input Voltage: 100-240V

Input Current: 0.6A

Input Frequency: 50/60Hz

Output Voltage: 15V

Output Current: 1.6A

Output Power: 24W

50

Description

Disposal of Product

Information

Please contact CVRx® representative to return product

to CVRx. Product should not be disposed of in trash.

51



11

Regulatory Notices

52

REGULATORY LABELING REQUIREMENTS

This system is equipped with an RF transmitter for wireless communications.

Each component has an RF identification number registered with the following regulating

agency:

Federal Communications Commission: FCC ID: SVHBAROSTIMIPG1 (all IPGs)

Federal Communications Commission: FCC ID: SVHBAROSTIMPGM1 (Model 9010

Programmer System)

Federal Communications Commission: FCC ID: SVHBAROSTIMPGM2 (Model 9020

Programmer System)

STATEMENT OF FEDERAL COMMUNICATIONS COMMISSION

(FCC) COMPLIANCE:

This device complies with Title 47, Part 15 of the FCC rules. Operation is subject to the

following two conditions:

• This device may not cause harmful interference, and

• This device must accept any interference received, including interference that

may cause undesired operation.

This transmitter is authorized by rule under the Medical Device Radio communication

Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations

operating in the 400.150–406.000 MHz band in the Meteorological Aids (i.e., transmitters

and receivers used to communicate weather data), the Meteorological Satellite, or the

Earth Exploration Satellite Services and must accept interference that may be caused by

such stations, including interference that may cause undesired operation. This transmitter

shall be used only in accordance with the FCC Rules governing the Medical Device Radio

Communication Service.

Analog and digital voice communications are prohibited. Although this transmitter has

been approved by the Federal Communications Commission, there is no guarantee that it

will not receive interference or that any particular transmission from this transmitter will

be free from interference.

53



12

Electromagnetic

Compatibility

Declarations

Model 9010

Programmer System

54



PROGRAMMER SYSTEM EMC PRECAUTIONS

The Model 9010 Programmer System needs special precautions regarding Electromagnetic

Compatibility (EMC) and needs to be installed and put into service according to the EMC

information provided in this guide.

Portable and mobile RF communications equipment can affect the Model 9010 Programmer

System.

The use of power cords or USB cables other than those supplied with the Model 9010

Programmer System may result in increased emissions or decreased immunity.

The Model 9010 Programmer System should not be used adjacent to or stacked with other

equipment. If such use is required, then the Model 9010 Programmer System should be

observed to verify normal operation in this configuration.

PROGRAMMER SYSTEM RF SPECIFICATIONS

The Model 9010 Programmer System may be interfered with by other equipment, even if

that other equipment complies with CISPR emission requirements. The RF telemetry

operating specifications are:

MICS band 402-405 MHz. The effective radiated power is below the limits specified in:

2.4 GHz band 2.4-2.4835 GHz. The effective radiated power is below the limits specified

in:

• USA: 47 CFR 95 Subpart I

• Canada: RSS-243

• USA: 47 CFR 15.249

• Canada: RSS-210

55



Table 14: Electromagnetic Emissions

Guidance and manufacturer’s declaration – electromagnetic emissions

The Model 9010 Programmer System is intended for use in the electromagnetic

environment specified below. The customer or the user of the Model 9010 Programmer

System should assure that it is used in such an environment.

Emissions Test

Compliance Electromagnetic environment – guidance

The Model 9010 Programmer System must emit

electromagnetic energy in order to perform its intended

function. Nearby electronic equipment may be affected.

The Model 9010 Programmer System is suitable for use in

all establishments, including domestic establishments and

those directly connected to the public low-voltage power

supply network that supplies buildings used for domestic

purposes.

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic

emissions

IEC 61000-3-2

Voltage

fluctuations /

flicker

emissions

IEC 61000-3-3

Group 1

Class B

Class A

Complies

56

Table 15: Electromagnetic Immunity

Guidance and manufacturer’s declaration – electromagnetic immunity

The Model 9010 Programmer System is intended for use in the electromagnetic environment

specified below. The customer or the user of the Model 9010 Programmer System should assure

that it is used in such an environment.

Immunity Test

IEC 60601 test level

Compliance level

± 1 kV differential

mode

± 2 kV common mode

Mains power quality should

be that of a typical

commercial or hospital

environment.

Electrostatic discharge

(ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Electrical fast

transient/burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short

interruptions and

voltage variations on

power supply input

lines

IEC 61000-4-11

Power frequency

(50/60 Hz) magnetic

field

IEC 61000-4-8

± 2 kV for power

supply lines

± 1 kV for

input/output lines

± 2 kV for power

supply lines

± 1 kV for

input/output lines

± 1 kV line(s) to

line(s)

± 2 kV line(s) to

earth

<5 % UT

(>95 % dip in UT for

0,5 cycle)

40 % UT

(60 % dip in UT for 5

cycles)

70 % UT

(30 % dip in UT for

25 cycles)

<5 % UT

(>95 % dip in UT for

5 s)

<5 % UT

(>95 % dip in UT for

0,5 cycle)

40 % UT

(60 % dip in UT for 5

cycles)

70 % UT

(30 % dip in UT for 25

cycles)

<5 % UT

(>95 % dip in UT for 5

s)

3 A/m

3 A/m

NOTE UT is the line voltage prior to application of the test level.

Electromagnetic

environment – guidance

Floors should be wood,

concrete or ceramic tile.

If floors are covered with

synthetic material, the

relative humidity should

be at least 30 %.

Mains power quality should

be that of a typical

commercial or hospital

environment.

Mains power quality should

be that of a typical

commercial or hospital

environment. If the user

of the Model 9010

Programmer System

requires continued

operation during power

mains interruptions, it is

recommended that the

Model 9010 Programmer

System be powered from

an uninterruptible power

supply or a battery.

Power frequency magnetic

fields should be at levels

characteristic of a typical

location in a typical

commercial or hospital

environment.

57

Guidance and manufacturer’s declaration – electromagnetic immunity

The Model 9010 Programmer System is intended for use in the electromagnetic environment specified below. The

customer or the user of the Model 9010 Programmer System should assure that it is used in such an environment.

IEC 60601 test level

Electromagnetic environment – guidance

Compliance

level

Immunity

Test

Conducted

RF

IEC 61000-4-

6

Radiated RF

IEC 61000-4-

3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2,5 GHz

3 V

3 V/m

Portable and mobile RF communications equipment should be

used no closer to any part of the Model 9010 Programmer

System, including cables, than the recommended separation

distance calculated from the equation applicable to the

frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2,5 GHz

where

is the maximum output power rating of the

transmitter in watts (W) according to the transmitter

is the recommended separation

manufacturer and

distance in meters (m).

Field strengths from fixed RF transmitters, as determined by

an electromagnetic site survey,a should be less than the

compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked

with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically

with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic

site survey should be considered. If the measured field strength in the location in which the Model 9010

Programmer System is used exceeds the applicable RF compliance level above, the Model 9010 Programmer

System should be observed to verify normal operation. If abnormal performance is observed, additional

measures may be necessary, such as re-orienting or relocating the Model 9010 Programmer System.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

58

Pd=35,3Pd=35,3Pd=37Pd

Table 16: Separation Distance

Recommended separation distance between portable and mobile RF communications equipment and

the Model 9010 Programmer System

The Model 9010 Programmer System is intended for use in the electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of the Model 9010 Programmer

System can help prevent electromagnetic interference by maintaining a minimum distance between

portable and mobile RF communications equipment (transmitters) and the Model 9010 Programmer

System as recommended below, according to the maximum output power of the communications

equipment.

Rated maximum output

power of transmitter

W

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

0,12

0,37

1,2

3,7

12

0,12

0,37

1,2

3,7

12

0,23

0,74

2,3

7,4

23

For transmitters rated at a maximum output power not listed above, the recommended separation

distance

in meters (m) can be estimated using the equation applicable to the frequency of the

is the maximum output power rating of the transmitter in watts (W) according

transmitter, where

to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects and people.

0,01

0,1

1

10

100

59

Pd=35,3Pd=35,3Pd=37dP13

Electromagnetic

Compatibility

Declarations

Model 9020

Programmer System

60



PROGRAMMER SYSTEM EMC PRECAUTIONS

The Programmer System requires special precautions regarding Electromagnetic

Compatibility (EMC) and is to be installed and put into service according to the EMC

information provided in this guide.

Portable and mobile RF communications equipment can affect the Programmer System.

The use of power cords or USB cables other than those supplied with the Programmer

System may result in increased emissions or decreased immunity.

The Programmer System should not be used adjacent to or stacked with other equipment.

If such use is required, then the Programmer System should be observed to verify normal

operation in this configuration.

PROGRAMMER SYSTEM RF SPECIFICATIONS

The Programmer System may be interfered with by other equipment, even if that other

equipment complies with CISPR emission requirements. The RF telemetry operating

specifications are:

MICS band 402-405 MHz. The effective radiated power is below the limits specified in:

2.4 GHz band 2.4-2.4835 GHz. The effective radiated power is below the limits specified

in:

• USA: 47 CFR 95 Subpart I

• Canada: RSS-243

• USA: 47 CFR 15.249

• Canada: RSS-210

61



Table 17: Electromagnetic Emissions

Guidance and manufacturer’s declaration – electromagnetic emissions

The Programmer System is intended for use in the electromagnetic environment specified

below. The customer or the user of the Programmer System should ensure that it is used

in such an environment.

Emissions Test

Compliance Electromagnetic environment – guidance

The Programmer System must emit electromagnetic

energy in order to perform its intended function. Nearby

electronic equipment may be affected.

The Programmer System is suitable for use in all

establishments, including domestic establishments and

those directly connected to the public low-voltage power

supply network that supplies buildings used for domestic

purposes.

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic

emissions

IEC 61000-3-2

Voltage

fluctuations /

flicker

emissions

IEC 61000-3-3

Group 1

Class B

Class A

Complies

62

Table 18: Electromagnetic Immunity

Guidance and manufacturer’s declaration – electromagnetic immunity

The Programmer System is intended for use in the electromagnetic environment specified below.

The customer or the user of the Programmer System should ensure that it is used in such an

environment.

Immunity Test

IEC 60601 test level

Compliance level

Electrostatic discharge

(ESD)

IEC 61000-4-2

±8kV contact

±2kV, ±4kV, ±8kV,

±15kV air

±8kV contact

±2kV, ±4kV, ±8kV,

±15kV air

Electrical fast

transients / bursts

IEC 61000-4-4

± 2 kV

100kHz repetition

frequency

± 2 kV

Surges

IEC 61000-4-5

Voltage dips and

interruptions

IEC 61000-4-11

± 0.5kV, ± 1 kV line-

to-line

± 0.5kV, ± 1 kV, ± 2

kV line-to-ground

± 0.5kV, ± 1 kV line-

to-line

± 0.5kV, ± 1 kV, ± 2

kV line-to-ground

0% UT

(100% dip in UT for

0,5 cycle)

At 0°, 45°, 90°,

135°, 180°, 225°,

270°, and 315°

0% UT

(100% dip in UT for 1

cycle)

70% UT

(30% dip in UT for

25/30 cycles)

Single phase: at 0°

0% UT

(100% dip in UT for

250/300 cycles)

0% UT

(100% dip in UT for

0,5 cycle)

0% UT

(100% dip in UT for 1

cycle)

70% UT

(30% dip in UT for

25/30 cycles)

0 % UT

(100% dip in UT for

250/300 cycles)

Rated power frequency

magnetic fields

IEC 61000-4-8

30 A/m

50Hz or 60Hz

30 A/m

NOTE UT is the line voltage prior to application of the test level.

Electromagnetic

environment – guidance

Floors should be wood,

concrete or ceramic tile.

If floors are covered with

synthetic material, the

relative humidity should

be at least 30%.

Mains power quality should

be that of a typical

commercial or hospital

environment.

Mains power quality should

be that of a typical

commercial or hospital

environment.

Mains power quality should

be that of a typical

commercial or hospital

environment. If the user

of the Programmer System

requires continued

operation during power

mains interruptions, it is

recommended that the

Programmer System be

powered from an

uninterruptible power

supply or a battery.

Power frequency magnetic

fields should be at levels

characteristic of a typical

location in a typical

commercial or hospital

environment.

63

Guidance and manufacturer’s declaration – electromagnetic immunity

The Programmer System is intended for use in the electromagnetic environment specified below. The customer or

the user of the Programmer System should ensure that it is used in such an environment.

Immunity Test

IEC 60601 test

level

Compliance

level

Electromagnetic environment – guidance

Conducted

disturbances

induced by RF

fields

IEC 61000-4-6

Radiated RF EM

fields

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

80 % AM at 1 kHz

3 V/m

80 MHz to 2,7 GHz

80 % AM at 1 kHz

3 Vrms

3 V/m

Portable and mobile RF communications equipment should

be used no closer to any part of the Programmer System,

including cables, than the recommended separation

distance calculated from the equation applicable to the

frequency of the transmitter.

Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2,5 GHz

where

is the maximum output power rating of the

transmitter in watts (W) according to the transmitter

is the recommended separation

manufacturer and

distance in meters (m).

Field strengths from fixed RF transmitters, as determined

by an electromagnetic site survey,a should be less than the

compliance level in each frequency range.b

Interference may occur in the vicinity of equipment

marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption

and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically

with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic

site survey should be considered. If the measured field strength in the location in which the Programmer

System is used exceeds the applicable RF compliance level above, the Programmer System should be observed

to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such

as re-orienting or relocating the Programmer System.

a

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

64

Pd=35,3Pd=35,3Pd=37PdTable 3: Immunity to Proximity Fields from RF Wireless Communications Equipment

Test

Frequency

(MHz)

Band

(MHz)

Service

Modulation

Max

power

(W)

Distance

(m)

Immunity

Test Level

(V/m)

Compliance

Test Level

(V/m)

1,8

0,3

27

27

385

380-390

TETRA 400

450

430-470

GMRS 460, FRS

460

710

745

780

810

870

930

1720

1845

1970

2450

5240

5500

5785

704-787

LTE Band 13,

17

800-960

1700-

1990

2400-

2570

GSM 800/900,

TETRA 800,

IDEN 820,

CDMA 850,

LTE Band 5

GSM 1800;

CDMA 1900;

GSM 1900;

DECT;

LTE Band 1, 3,

4, 25; UMTS

Bluetooth,

WLAN,

802.11 b/g/n,

RFID 2450,

LTE Band 7

5100-

5800

WLAN 802.11

a/n

Pulse

modulation

18Hz

FM

± 5 kHz

deviation

1kHz sine

Pulse

modulation

217 Hz

Pulse

modulation

18Hz

Pulse

modulation

217 Hz

Pulse

modulation

217 Hz

Pulse

modulation

217 Hz

2

0,3

28

28

0,2

0,3

9

9

2

0,3

28

28

2

0,3

28

28

2

0,3

28

28

0,2

0,3

9

9

65

Table 4: Separation Distance

Recommended separation distance between portable and mobile RF communications equipment and

the Programmer System

The Programmer System is intended for use in the electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the Programmer System can help prevent

electromagnetic interference by maintaining a minimum distance between portable and mobile RF

communications equipment (transmitters) and the Programmer System as recommended below,

according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,5 GHz

Rated maximum output

power of transmitter

W

0,01

0,1

1

10

100

0,12

0,37

1,2

3,7

12

0,12

0,37

1,2

3,7

12

0,23

0,74

2,3

7,4

23

For transmitters rated at a maximum output power not listed above, the recommended separation

distance

in meters (m) can be estimated using the equation applicable to the frequency of the

is the maximum output power rating of the transmitter in watts (W) according

transmitter, where

to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects and people.

66

Pd=35,3Pd=35,3Pd=37dP

CVRx, BAROSTIM, NEO, BAROSTIM NEO, BAROSTIM NEO2, BAT and BAROSTIM THERAPY are all trademarks of CVRx,

Inc.

All other trademarks are property of their respective owners.

For a list of applicable patents, see www.cvrx.com/patent-marking.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

©2021 CVRx, Inc. All rights reserved.

67



900133-001 Rev. B V1.10

2021-08

0



 

 

 

 

 

 

 

 

 

 

Marking Plate CVRx Model 9020 Label FCC ID: SVHBAROSTIMPGM2 Page 1 of 2 Warning Label CVRx Model 9020 Label FCC ID: SVHBAROSTIMPGM2 Page 2 of 2

 

 

Back, Hinge Stowed CVRx Model 9020 Label Locations FCC ID: SVHBAROSTIMPGM2 When the hinge is rotated, the marking plate is fully visible. Warning Label Marking Plate

(Under Hinge) Page 1 of 1

 

 

2021-08-03 Attention: Application Examiner RE: Request for Confidentiality Applicant: CVRx, Inc. FCC ID: SVHBAROSTIMPGM2 To Whom It May Concern:

Permanent Confidentiality Request is hereby submitted by CVRx, Inc. to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential:

e Parts List Model 9020 e Block Diagram Model 9020 e Operational Description Model 9020 e Schematic Diagram Model 9020 Short-term Confidentiality Request is hereby submitted by CVRx, Inc. to withhold from public review for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing, certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept confidential for a period of 180 days from the date of Authorization:

e Internal photos Rationale for request for confidentiality:

CVRx, Inc. has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. Disclosure of the short-term confidential portions of this application during the period of importation and/or distribution would reveal key aspects of proprietary technology to competitors and diminish the value of our investment in research and development. If you have questions or need further information, please contact the undersigned. oer ea ee 9201 West Broadway Avenue, Suite 650, Minneapolis, MN 55445 Phone (763) 416-2840 Fax (763) 416-2841 WWw.cvFX.com PAGE 1 OF 2 CVRX Sincerely, _ jae oy Dee Bate o Dean Bruhn-Ding Vice President, Regulatory Affairs & Quality Assurance CVRx, Inc. Email: dbruhn-ding@cvrx.com Phone: 763-416-2855 Fax: 763-416-8405 9201 West Broadway Avenue, Suite 650, Minneapolis, MN 55445 Phone (763) 416-2840 Fax (763) 416-2841 WWW.CVFxX.com PAGE 2 OF 2

 

 

CVRx 2021-04-07 Intertek Testing Services NA Ltd. 70 Codman Hill Road Boxborough, MA 01719 Subject: Limited Agency Agreement CVRx, Inc. FCC ID: SVHBAROSTIMPGM2 To Whom It May Concern:

We, CVRx, Inc., hereby authorize Greg Turnipseed of The Realtime Group to act as our Agent for the purpose of preparing the application for FCC ID number SVHBAROSTIMPGM2 under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is 2021-04-07. The Limited Agency Agreement expires on 2022-04-07, unless sooner terminated or extended by written notice to Intertek Testing Services and the Federal Communications Commission. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. The applicant is not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 U.S.C. 862, and no party to the application is subject to a denial of federal benefits pursuant to that section. If you have any questions or comments, please do not hesitate to contact me. Dice Lark ay Dean Bruhn-Ding Vice President, Regulatory Affairs & Quality Assurance CVRx, Inc. 9201 West Broadway, Suite 650, Minneapolis, MN 55445 Phone (763) 416-2840 Fax (763) 416-8405 www.cvn.com

 

 

CVRx 2021-04-07 Federal Communications Commission 445 12 Street SW Washington, DC 20554 Subject: Limited Agency Agreement CVRx, Inc FCC ID: SVHBAROSTIMPGM2 To Whom It May Concern:

We, CVRx, Inc, hereby authorize Intertek Testing Services to act as our Agent for the purpose of preparing application for FCC ID number SVHBAROSTIMPGM2 under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is 2021-04-07. The Limited Agency Agreement expires on 2022-04-07, unless sooner terminated or extended by written notice to Intertek Testing Services and the Federal Communications Commission. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. The applicant is not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 U.S.C. 862, and no party to the application is subject to a denial of federal benefits pursuant to that section. If you have any questions or comments, please do not hesitate to contact me. Sincerely, Dean Bruhn-Ding Vice President, Regulatory Affairs & Quality Assurance CVRx, Inc. 9201 West Broadway, Suite 650, Minneapolis, MN 55445 Phone (763) 416-2840 Fax (763) 416-8405 www.cvrx.com