Avery Biomedical Devices

Avery Biomedical Devices, Inc. is a company developing a Breathing Pacemaker System. The system is a phrenic nerve stimulator, also called a diaphragm pacemaker. It consists of surgically implanted receivers and electrodes mated to an external transmitter by antennas worn over the implanted receivers. Phrenic pacing provides ventilatory support for patients with chronic respiratory insufficiency whose diaphragm, lungs, and phrenic nerves have residual function.

The Avery Breathing Pacemaker System has received premarket approval from the US Food and Drug Administration (FDA) and Certification Marking (CE) to be sold in the European Economic Area.

The company is located in Commack, New York on Long Island approximately 50 miles east of New York City. In July 2015, Dr. Dilys Gore, Tony Martins and Linda Towler (CEO), three long-time employees of Avery Biomedical Devices, purchased majority ownership of the company from the Estate of Claire Dobelle.

The device received full pre-market approval from the FDA in 1987, and is the only such device with this approval. A similar device developed in Finland is approved for use in Europe. The device is placed as an alternative to the traditional ventilator in patients with quadriplegia, central sleep apnea, diaphragm paralysis, and other respiration maladies, so long as the patient's respiratory system still has some residual function.

In 2019, Avery received full premarket approval from the United States Food and Drug Administration for the Spirit Transmitter. The Mark IV Breathing Pacemaker, and subsequent Spirit Diaphragm Pacemaker, is a phrenic nerve stimulator, also called a diaphragm pacemaker. Phrenic nerve stimulation is a technique whereby a nerve stimulator provides electrical stimulation of the phrenic nerve to cause diaphragmatic contraction. It consists of surgically implanted receivers and electrodes mated to an external transmitter by antennas worn over the implanted receivers. An external battery-operated transmitter sends radiofrequency energy to the receiver through an antenna, which is placed on the skin overlying the receiver. The receiver converts this energy into an electric current that is directed to the phrenic nerve in order to stimulate the nerve, thereby causing contraction of the diaphragm. The surgery can be performed via either a cervical or thoracic approach. Phrenic pacing provides ventilatory support for patients with chronic respiratory insufficiency whose diaphragm, lungs, and phrenic nerves have residual function.