Avery Biomedical Devices

Avery Biomedical Devices is a biomedical engineering and device company that invented and distributes the Mark IV Breathing Pacemaker, a Phrenic Nerve Pacing device used for patients in the United States. The device received full pre-market approval from the FDA in 1987, and is the only such device with this approval.[1] 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.[2]

In 2019, Avery received full premarket approval from the United States Food and Drug Administration for the Spirit Transmitter[3].

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.[4] Phrenic pacing provides ventilatory support for patients with chronic respiratory insufficiency whose diaphragm, lungs, and phrenic nerves have residual function.[2][5]