NextGen Diaphragm Pacing Transmitter for Central Sleep Apnea Earns FDA Approval
Avery Biomedical Devices has earned FDA approval for its next-generation diaphragm pacemaker transmitter, Spirit, and is now being offered to patients using its pacing system. Indications for use include chronic respiratory insufficiency due to central sleep apnea, congenital hypoventilation syndrome, high spinal cord injuries, acute flaccid myelitis, various central neurological disorders, autoimmune diseases including multiple sclerosis, and diseases caused by insect bites like Lyme disease.
Linda Towler, Avery CEO, says in a release, “At Avery, our R&D activities have always been focused on improving the quality of life and safety of those patients using our diaphragm pacemakers. Our Spirit Diaphragm Pacing Transmitter offers an elevated level of user-friendly features that deliver our hallmark reliability and performance with added convenience.”
The Spirit Transmitter features a clear graphic display with touch controls that are not unlike those on a smart phone. Other valuable features include: backlighting for night viewing, audible and visual alarms, keypad locks, and water resistant protection. For high reliability, the transmitter features bilateral redundancy.
The Spirit diaphragm pacing system has FDA PMA approval and CE marketing privileges for all ages. It is ISO 13485: 2016 compliant.
from Sleep Review https://www.sleepreviewmag.com/sleep-treatments/therapy-devices/neurostimulators/spirit-diaphragm-pacing-transmitter/