Is Diaphragm Pacing Safe?

Avery Biomedical Devices (ABD) has been the leader in providing diaphragm pacing systems to help those with Spinal Cord Injury (SCI), Congenital and Acquired Central Sleep Apnea, and other forms of Diaphragm Paralysis to achieve a patient-reported higher quality of life and a lower cost of care option compared to mechanical ventilation. As with any surgically implanted device, however, there is always the question of potential risks and welfare factors. It is normal for people to weigh safety concerns about diaphragm pacing devices and then ultimately decide which diaphragm pacemaker on the market is the safest and provides the least amount of risk for them. Avery Biomedical has put safety as a primary concern in the development of the Avery Diaphragm Pacing System. With five decades of research and documented lack of adverse effects on record, we take pride in providing what we believe to be the safest diaphragm pacing system on the market.

What makes the Avery Diaphragm Pacing System safer, combined with fewer risks, than other devices on the market?

The Avery Diaphragm Pacing System has had full FDA approval from the FDA since the inception of the requirement in 1986. It is the only device that has full FDA approval and CE Marking Privileges in the EU for both adolescent and pediatric use, whereas the other has clearance only for adult use under a humanitarian exemption. In addition, the Avery Pacemaker has 50 years of experience with well documented safety and reliability compared to an unknown safety. Since its development, Avery Biomedical has been diligent in creating devices that limit or eliminate potential safety risks.

Bilateral Redundancy

Compared to a competitor device that uses a multiple electrode design subject to additional potential failure points, Avery Diaphragm Pacing System is designed with bilateral redundancy for superior safety. Each diaphragm is paced by its own implanted receiver, electrode, and external transmitter and antennas. This independence provides an extra margin of safety as there is no single point failure which could cause the entire system to stop working. These devices have also been subject to rigorous environmental and electromagnetic testing by independent and certified laboratories to ensure safety and efficacy. In addition, the Avery system is fully implantable versus the competitor device in which wires protrude through the skin.

The question, ‘what if the pacemaker stops working?’ is a genuine cause for concern. With the Avery Diaphragm Pacing System, if one side fails, the other side still contracts the diaphragm. Competitors lack bi-lateral redundancy, a vital safety and reliability feature. In addition, the Avery Diaphragm Pacing System uses external AA batteries, alleviating additional surgeries should replacement be needed. Another system requires surgical procedures estimated every 1.4 to 4.5 years to replace the implantable pulse generator.

Minimally Invasive Procedure

Providing the most minimally invasive surgical procedure is of utmost importance to ABD. Avery has two minimally invasive methods for surgical pacemaker placement to provide the safest implantation possible. The thoracic approach procedure can be performed using VATS (video-assisted thoracic surgery) techniques allowing for significantly smaller incisions. The cervical approach is also considered minimally invasive since it does not require a thoracotomy, or other chest procedure, does not involve entering any body cavity, and uses one (3-5 cm) incision. These two methods are in contrast to a competitor system that requires a laparoscopy, creating four incisions in the abdomen prior to placing four electrodes along the motor points of the phrenic nerves. Special equipment is also needed.

Reduced Infection Risk

Avery’s System is fully implantable.
The receiver located just under the skin receives radio-frequency energy from the transmitter/antenna. The receiver then converts the radio waves into stimulating pulses. These pulses are then sent through the electrodes to the phrenic nerve causing the diaphragm(s) to contract. Unlike the other diaphragmatic system that has percutaneous lead wires, a constant infection risk and presenting ongoing wound care management issues. Wound care with such a system needs to be performed at least every three days for the life of the patient. Additionally, such wires provide an electrical conduction path from an external source (the stimulator) to inside the body (the diaphragm). Accidental contact between a percutaneous lead and other conductive elements could cause tissue damage or other injury.

Leading the Way in Diaphragm Pacing

Avery has taken into account the importance of developing a Diaphragm Pacing system that will not interfere or inadvertently cause other health conditions. Whereas, the Avery system does not disturb heart function, other systems have had a history including risk of cardiac arrhythmia, ventricular fibrillation, and cardiac arrest. Similarly, there is no incidental risk of intraoperative hypotension or capnothorax complications with the Avery Diaphragm Pacing System which does exist with other devices.

With the long term proven history of safety, lack of adverse effects reported, fewer reported infections and hospital stays, The Avery Diaphragm Pacing System has paved the way and created the highest standard for diaphragm pacing systems. ABD has provided risk averse solutions to individuals needing a life-saving or quality of life enhancing diaphragm pacing solution indicated for SCI, Central Sleep Apnea and other forms of diaphragm paralysis that is safe, reliable and more cost effective. It is because of this and more that Avery is to be considered the leader in diaphragm pacing systems.

Get More Information on the Avery Diaphragm Pacemaker

If you would like more information on the Avery Diaphragm Pacemaker, please contact us via our contact form, phone (631-864-1600), or use our doctor search to find a physician near you who has experience with the device.

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