What if you had two choices for diaphragmatic pacing?
Choice A has:
Full FDA PMA approval for adults & pediatrics
Over 45 years of experience
Proven long-term safety record
Reduced risk of infections and need for wound care
Choice B has:
HDE exemption for adults with SCI or ALS
A little over 12 years of experience
Unknown long-term safety record
Additional risk of infection due to protruding wires
No redundancy. Single-point system failure
On top of all that, the second choice is more expensive than the first.
We believe the choice becomes obvious, and choice A is the Avery Diaphragm Pacemaker.
Below, we have included a direct comparison of the Avery Diaphragm Pacemaker and the leading competitor’s diaphragm pacing system. 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 call us at 631-864-1600 or contact us to request more information. We are here to help you!
|Criteria||Avery Biomedical||Competitor Device|
|Surgical approach1||Cervical or Thoracic||Abdominal|
|Full FDA approval2||Yes||No|
|Pre-operative assessment to optimize outcomes4||Yes||No|
|Local/monitored anesthesia6||Yes (Cervical Approach)||No|
|Reduced risk of infection7||Yes||No|
|System fully implantable8||Yes||No, Wires Protruding Through The Skin|
|Need for ongoing, routine wound care9||No||Yes|
|Risk of tissue damage11||No||Yes|
|Years of experience with device12||> 45 years||> 12 years|
|Risk of intra-operative hypotension13||No||Yes|
|Number of Anodes15||2||1|
|Number of Cables16||2||1|
|Battery17||Standard 9-Volt Batteries||Specialized Lithium Battery|
|Parameter adjustments by patient or caregiver18||Yes||No|
|Additional equipment needed19||No||Special Clinical Station Console|
|Maximum stimulation current20||10mA||25mA|
|Maximum stimulation voltage21||10 V||50 volt D.C.|
|Cardiac pacemaker22||Can Be Implanted||Cannot Be Implanted|
|Long-term pacing safety23||Proven||Unknown|
|Interference with the heart24||No||Yes, Risk of Cardiac Arrhythmia|
1Avery allows for either cervical or thoracic (thorascopic/VATS, robotic, uniportal VATS) approach whereas the competitor system requires several small incisions throughout the abdomen.
2The Avery Diaphragm Pacemaker system is the only device of its kind with full premarket approval from the US FDA. The competitor device holds a humanitarian device exemption (HDE) according to which “the effectiveness of this device for this use has not been demonstrated”
3The Avery device is indicated in all ages. The competitor device has HDE approval for those >18 years of age
4Candidacy for the Avery Diaphragm Pacemaker can be determined through a non-invasive pre-operative phrenic nerve conduction study. Candidacy for the competitor device can only be done inter-operatively during the procedure. If the nerves aren’t viable the procedure is abandoned. (R.P. Onders, MD “Functional electrical stimulation: restoration of respiratory function”, Handbook of Clinical Neurology, vol. 109).
5The Avery Diaphragm Pacemaker has never necessitated an adverse event report in its 40+ year history. The competitor device has been the subject of at least 17 FDA Adverse Event Report filings since December 2009.
6Only the Avery device through the cervical approach can be implanted without the use of general anesthesia.
7The 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.
8(See previous) The Avery device is fully implanted beneath the skin with the power to the device being supplied externally via radio waves through the skin.
9With the Avery Diaphragm Pacemaker no wound care is needed after the incisions are healed. The patient can take baths, showers or do water therapy.The competitor device has five wires that protrude from an open wound requiring wound care for life. Additionally, the manual states: “Change dressings every 3 days or more often if the dressing becomes wet or otherwise soiled.
10Capnothorax is a condition where carbon dioxide is introduced into the thoracic cavity. This is a potential complication of the competitor device, which can result in temporary placement of catheters in the chest cavity or an extended hospital stay while the condition resolves. [Clinics (São Paulo). 2012 Nov; 67(11):1265-9]
11There is risk of tissue damage with the competitor device because of the high operating voltage needed. The competitor manual says “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)
12First commercial device 1971.
13Intra-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).
14The 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.”
15The 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.
16The Avery Biomedical System has two cables (antennas) connected to the external stimulator. If one antenna comes off the skin, gets disconnected or breaks, the other antenna continues to stimulate. The competitor device has only one cable from the external stimulator to the four electrodes and the anode. If the cable breaks or gets disconnected, no stimulation is possible.
17The Avery Diaphragm Pacemaker is powered by two inexpensive 9-Volt alkaline batteries available in any store anywhere in the world. The competitor device is powered by an expensive Lithium / Thionyl Chloride battery not available in stores. The manual states: “Use only SPECIAL size “C” lithium batteries. Do not use a standard alkaline battery in the stimulator. The size “C” lithium batteries can be obtained from [the company].”
18Avery 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.
19The 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)
20The 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.
21The 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.”
22A 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.”
23Long-term pacing with the Avery Diaphragm Pacemaker has been proven to be safe. There are patients pacing for more 30 years. The manual of the competitor device advises that “The long-term effects of electrical stimulation of the diaphragm are unknown.”
24The 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.”