System Comparisons

AVERY– The Clear Choice for Diaphragm Pacing

Compare The Competition

We believe the choice is obvious...
and the choice is the Avery Diaphragm Pacemaker

Below, we have included a direct comparison of the Avery Diaphragm Pacemaker and the Synapse NeuRx® device. Included in the comparison are notes detailing the specific findings and what they mean. At Avery, we firmly believe that we have the best device on the market and that the data clearly shows this.

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, please Contact Us to request more information.

AVERY vs. NeuRx® 

The Avery Diaphragm Pacer and the Synapse NeuRx® both stimulate the phrenic nerve, causing the diaphragm to contract. However, that is where the similarities end.

The Avery Device:

The NeuRx® Device:

System Comparison Chart

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
No
ref.2
Adverse Events
No
Yes
ref.3
Reduced Risk of Infection
Yes
No
System Fully Implantable
Yes
Wires protruding through the skin
Need for Ongoing, Routine Wound Care
No
Yes
ref.4
Risk of Tissue Damage
No
Yes
Years of Experience With Device
> 50 years
> 20 years
ref.5
Risk of Intra-Operative Hypotension
No
Yes
ref.6
Bilateral Redundancy
Yes
No
ref.7
Number of Anodes
2
1
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
No
ref.10
Additional Equipment Needed
No
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
No
Yes
ref.14
Long-Term Pacing Safety
>50 Years
PMA Received on 3/31/2023
ref.15
Interference With The Heart
No
Risk of Cardiac Arrhythmia
Uses standard surgical tools
Yes
Specialized Surgical Tools Required

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.”

15 Interference 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.”

AVERY vs. Remedé

Central Sleep Apnea System Comparison

Central sleep apnea is a disorder that causes individuals to have one or more pauses in breathing or shallow breaths during sleep. Breathing pauses can last from a few seconds to minutes. Central sleep apnea occurs when the brain fails to send signals to the diaphragm to breathe, causing an individual to stop breathing during sleep for a period of 10 seconds or more before restarting again. According to the National Institute of Health’s National Center on Sleep Disorders Research, central sleep apnea can lead to poor sleep quality and may result in serious health issues, including an increased risk for high blood pressure, heart attack, heart failure, stroke, obesity, and diabetes. Common treatment options for moderate to severe sleep apnea include medication, positive airway pressure devices (e.g., continuous positive airway pressure machine), or surgery.

Listed in the chart below are the only two surgical options for CSA:

System Comparison Chart

Criteria
AVERY Biomedical
Remedé
Electrode Through Veins
No
Yes
Additional Surgeries to Replace Battery
No Surgeries Required to Replace Batteries. External AA Batteries
Yes Surgical Procedure is Required Every 1.4 Years to 4.5 Years (estimate) to Replace Implantable Pulse Generator
Risk of Failure
If One Side Fails, The Other Side Still Contracts The Diaphragm
Stimulates One Side of The Diaphragm. Therapy Stops if There is No Stimulation
Stimulation Effectiveness
Left And Right Side of The Diaphragm Contracts
Only One Side of The Diaphragm Contracts
Approved For All Ages
Pediatric and Adults
Adults Only
Long-Term Pacing Safety
Well Documented
Unknown
Full FDA Approval
FDA Approval Since January 1987
FDA Approval Since October 2017

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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, please Contact Us to request more information.

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