The Avery Diaphragm Pacing System

Breath Giving, Life Changing

The Avery Diaphragm Pacing System is a fully implantable system designed to provide improved quality of life through vent-free breathing.

It is the only diaphragm pacemaker on the market with full FDA Approval and CE Marking Privileges for adult and pediatric use.

For information about the system, or to find a physician with experience in diaphragm pacing, please contact us and we will be happy to assist you.

How It Works

The Avery Diaphragm Pacing System consists of surgically implanted receivers and electrodes and an external transmitter with antennas worn directly over the implanted receivers.

The external transmitter and antennas send radiofrequency energy to the implanted receivers just under the skin. The receivers then convert the radio waves into stimulating pulses.

These pulses are then sent down the electrodes to the phrenic nerves, causing the Diaphragms to contract. This contraction causes inhalation of air. When the pulses stop, the diaphragms relax and exhalation occurs. Repetition of this series of pulses produces a normal breathing pattern.

The Avery Advantage

The Avery Diaphragm Pacing system has numerous advantages, including:

Unlike other systems, the Avery transmitter is entirely self-contained and does not require a complicated external programmer to configure it. End user controls allow patients and their caregivers the flexibility to adjust the system as needed. They also use standard alkaline batteries which are readily available worldwide.

Why Choose Avery?

Safety

Unsurpassed Record of
Safety and Reliability

Minimal Care

Reduced Risk of Infections, Hospitalizations
and No On-Going Wound Care

Mobility

Allows for
Greater Independence

Water Therapy

Shower, Bathe and
Participate in Water Therapy

For All Ages

FDA PMA Approval and
CE Marking EU Privileges

Bilateral Redundancy

Dual Redundant Design –
No Single-Point Failure

Lower Cost

Higher Quality with
Lower Cost of Care

Industry Leader

Medical Leader in Diaphragm Pacemakers
for Over 50 Years

How Does Avery Compare?

Reference

Criteria

AVERY Biomedical

Synapse NeuRx®

ref.1

Surgical Approach

Cervical, Thoracic (VATS/Robotic)

Abdominal

For Adult and Pediatric Use

Yes

Limited to SCI 18yrs & Older

Shower, Bathe and Participate in Water Therapy

Yes

ref.2

Adverse Events

Yes

ref.3

Reduced Risk of Infection

Yes

System Fully Implantable

Yes

Wires protruding through the skin

Need for Ongoing, Routine Wound Care

Yes

ref.4

Risk of Tissue Damage

Yes

Years of Experience With Device

> 50 years

> 20 years

ref.5

Risk of Intra-Operative Hypotension

Yes

ref.6

Bilateral Redundancy

Yes

ref.7

Number of Anodes

ref.8

Alkaline Battery

1.5 Volt AA-size

1.5 Volt C-size or 3.6 Volt Lithium Battery

ref.9

Parameter Adjustments by Patient or Caregiver

Yes

ref.10

Additional Equipment Needed

Special Clinical Station Console

ref.11

Maximum Stimulation Current

10mA

25mA

ref.12

Maximum Stimulation Voltage

10 Volt D.C.

50 Volt D.C.

ref.13

Cardiac Pacemaker Contraindicated

Yes

ref.14

Long-Term Pacing Safety

>50 Years

PMA Received on 3/31/2023

ref.15

Interference With The Heart

Risk of Cardiac Arrhythmia

Uses standard surgical tools

Yes

Specialized Surgical Tools Required

Need More Information?

At Avery Biomedical Devices, we are committed to helping those with breathing difficulties and improving the quality of life. If you have any questions regarding the Avery Diaphragm Pacemaker System and the specific benefits of choosing the system, or if you are a prospective patient looking for assistance finding a doctor familiar with the device and diaphragm pacing, please Contact Us to request more information.

We are here to help!

References:

¹Surgical Approach

Avery allows for either cervical or thoracic (thorascopic/VATS, robotic, uniportal VATS) approach whereas the competitor system requires several small incisions throughout the abdomen.

² Adverse Events

³Reduced Infections

The Avery electrode is fully implantable and uses radiofrequency energy transmitted through intact skin to power the electrode. The competitor device has five wires protruding from the skin, necessitating ongoing wound care.

⁴Risk of Tissue Damage

There is risk of tissue damage with the competitor device because of the high operating voltage needed. The competitor manual states “Output voltages may approach 50 volt D. C. during operation.” The low voltage needed with the Avery device has been shown to not put tissue at risk for damage (J. of Pacing and Clinical Electrophysiology 23(6) June 2002)

⁵Risk of Intra-operative hypotension

Intra-operative hemodynamic instability can develop with the competitor device procedure because of the carbon dioxide introduced into the abdomen. (Anesthesia Intensive Care 2010; 38:740-743).

⁶Bilateral Redundancy

The Avery Diaphragm Pacemaker has two independent circuits, one for each side with its own controls, powered by its own battery and with its own antenna. If one side does not pace, the other continues pacing independently. The competitor device has one circuit and one battery for the entire system. If it stops operating, or if the battery is dead, neither side paces. The competitor manual states: “It is possible that stimulation from the diaphragm pacing system could stop either due to electrode breakage, cable disconnection, or stimulator failure. If one of these happens, breathing will stop. Without prompt attention, this could result in permanent disability or death.”

⁷Number of Anodes

The Avery Biomedical System has two implants, one for each side. Each implant has an electrode and its own anode, increasing redundancy. If one side fails, the other side continues to stimulate. The competitor device has four electrodes, but only one anode. If the anode lead wire is broken or does not make good contact, stimulation is not possible with any of the four electrodes.

⁸Alkaline Batteries

The Avery Diaphragm Pacemaker is powered by 4 inexpensive 1.5 Volt AA-size alkaline batteries available in any store anywhere in the world. These batteries last >400 hours when using factory default parameters. The competitor device is powered by a C-size 1.5 Volt alkaline battery. An expensive 3.6 Volt lithium battery can be used as an alternative. The manual states: “Replace the Alkaline battery every 96 hours of the NeuRx EPG use. This is about every 4 days if you are using NeuRx DPS full time”

⁹Parameter Adjustments

Avery Diaphragm Pacemaker has controls so that parameters can be adjusted by the patient (on/off, amplitude and respiratory rate). The competitor’s pacemaker has an on/off button without any possible adjustment of parameters. The patient cannot adjust the respiratory rate or the amplitude.

¹⁰Additional Equipment Needed

The Avery Diaphragm Pacemaker requires no additional equipment to adjust the parameters. The competitor device requires an expensive Clinical Station console necessary during the surgical procedure to stimulate the diaphragm to find the best location to implant the electrodes, used by the doctor to optimize the settings for comfort and effect, and used to program the desired settings into the device. (taken from company website)

¹¹Maximum Stimulation Current

The Avery Diaphragm Pacemaker can generate a maximum stimulus current of 10 mA for each of the two implanted electrodes. Typical stimulus amplitude ranges from 1 mA to 5 mA. The competitor device can generate a maximum of 25 mA for each of the four implanted electrodes. Its minimum stimulus amplitude is 5 mA.

¹²Maximum Stimulation Voltage

The Avery Diaphragm Pacemaker generates a maximum voltage of 10 V. Typical stimulus voltage ranges from 1 V to 5 V. The competitor manual states: “output voltages may approach 50 volt D.C. during operation.”

¹³Cardiac Pacemaker

A cardiac pacemaker is not contraindicated in patients with an Avery Biomedical pacemaker. The competitor manual warning says “Do NOT use in patients with implanted electronic device (insufficient data is available, at this time, to establish safety with a cardiac pacemaker).” It also advises that “At this time, there is insufficient clinical data to determine safety in implanting patients with cardiac pacemakers, therefore, you should not be implanted with this device if you have a cardiac pacemaker or other implanted electrical device.”

¹⁴Long-term pacing safety

Long-term pacing with the Avery Diaphragm Pacemaker has been proven to be safe. There are patients pacing for more than 40 years. The manual of the competitor device advises that “The long-term effects of electrical stimulation of the diaphragm are unknown.”

¹⁵Interference with the Heart

The Avery Diaphragm Pacemaker does not interfere with the heart rhythm. The manual of the competitor device states “there is a risk of cardiac arrhythmia being caused by the placement of the electrodes in the chest cavity.”