The Avery Biomedical Devices diaphragm pacemaker transmitter, Spirit, has earned FDA approval and is now being offered to patients using its pacing system, according to the company.
This NextGen transmitter features a light-weight compact design with easy-to-use touch controls and offers precision-enhancing digital circuitry.
Avery Chief Executive Officer Linda Towler stated, “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 making it a familiar design and easy to use. Other valuable features include: backlighting for night viewing, audible and visual alarms, keypad locks and water resistant protection. To ensure its high reliability, the transmitter features bilateral redundancy.
Avery is the only diaphragm pacing system that has FDA PMA approval and CE marketing privileges for all ages, according to Avery Biomedical. The device is also ISO 13485: 2016 compliant.
For those patients who meet the criteria of having functional lungs and diaphragm muscle, as well as an intact phrenic nerve, they can be cleared for the device.
It consists of surgically implanted electrodes and receivers with an external transmitter and antennas. The transmitter and antennas send radio frequency energy to the implanted receivers just under the skin. The receivers convert the radio waves into stimulating pulses which are sent through the electrodes to the phrenic nerves, causing the diaphragm to contract. This contraction causes inhalation of air, and when the pulses stop, the diaphragm relaxes, and exhalation of air occurs.