System Information

VENT-FREE BREATHING

Phrenic Nerve Stimulation Provides an Improved Quality of Life

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System Details – Spirit Transmitter

The Spirit Diaphragm Pacing Transmitter is CE Marked under the European Active Implantable Medical Device Directive as of 2017, and received full FDA Approval in November 2019. The transmitter is lightweight and features a backlight for nighttime viewing, clear graphic display, touch controls, and digital precision. For safety, it is also water resistant, has keypad locks, utilizes audible and visual alarms, and features bilateral redundancy.

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Receivers And Electrodes

The implanted receiver is a small electronic device, about the size of a US quarter and approximately 1/4″ thick, that receives radiofrequency energy and converts it to electrical impulses which stimulate the diaphragm. The implanted electrode is a highly flexible stainless steel wire, insulated by silicone rubber, with a platinum nerve contact on one end, and a connector that mates with the receiver at the other.

System Details – Mark IV Transmitter

In March 1998, the U.S. Food and Drug Administration gave premarket approval (PMA) to the new Mark IV external transmitter for adult and pediatric patients who have lost neurological control of respiration. FDA premarket approval is required before Class III medical devices can be commercially distributed in the United States.
In advance of FDA approval, the Mark IV had been distributed in 24 countries worldwide. The Mark IV qualified for the CE Mark under the European Active Implantable Medical Device Directive in 1995.

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Antennas

An external antenna is worn over each implanted receiver and sends power and radio signals from the transmitter to the receiver transcutaneously. This radiofrequency coupled design means that there are no wires or plugs protruding from the skin, and no batteries in the implant that would require periodic replacement.

An antenna is a durable disposable item which requires periodic replacement. It is recommended that antennas be replaced prophylactically every six months. Antennas are available in one-meter and two-meter lengths.

Antennas do not contain latex. Additionally, no latex products are used in their manufacturing. Instructions for the use and care of antennas can be found here.

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Recommended Physician Referrals

Avery Biomedical Devices works with physicians, specialists and a select number of surgeons throughout the United States for the implementation of the Avery Diaphragm Pacemaker. To find our top recommended specialists near you, please Contact Us directly through one of the following methods and we will be happy to connect you to a physician, specialist or surgeon that is familiar with the device and may further assist you and your specific needs.

The Avery Diaphragm Pacemaker has been implanted in patients in over 44 countries around the world.

For International Physicians please Contact Us to provide a referral. 

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The Leader In Diaphragm Pacemakers
FDA Approved for All Ages
Since 1987

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