University Hospitals Ventures
04/05/2023 | Press release | Archived content
Oberlin-based Synapse Biomedical receives FDA approval for breathing device used by Christopher Reeve
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Oberlin-based Synapse Biomedical receives FDA approval for breathing device used by Christopher Reeve
Published April 5, 2023 | By Gretchen Cuda Kroen, cleveland.com
OBERLIN, Ohio - Synapse Biomedical, a medical device company based in Oberlin, received FDA premarket approval Wednesday for a breathing device that allows patients with spinal cord injuries to breathe without the use of a ventilator.The development of the breathing device, called the NeuRx diaphragm pacing system, has been 20 years in the making. It was first implanted at University Hospitals in a prospective clinical investigation in 2000. Since then it was tested in over 2,500 patients worldwide, including the late actor Christopher Reeve, ahead of approval by the FDA. The device, installed at UH in Cleveland, freed Reeve from constant need of a ventilator.
NeuRx DPS allows for a more natural method of breathing. Rather than forcing air into the patient's lungs, the muscles of the diaphragm are stimulated with battery powered electrodes to expand and draw air in.
It can be used in patients with spinal cord injuries whose muscles still respond to electrical stimulation but the patients cannot consciously control the diaphragm themselves.
Although originally designed to allow for breathing without the assistance of a mechanical ventilator for four hours a day, the company says many patients have gone on to use the device as long as 24 continuous hours.
The company says they expect more hospitals to begin implementing the NeuRx DPS now that they no longer have to undergo the lengthy internal review and approval process required under the exemption.
The system was pioneered by Raymond Onders, chair of surgical innovation at UH Cleveland Medical Center, and J. Thomas Mortimer, professor emeritus of Biomedical Engineering at CWRU.
"The new FDA approval is great news for patients," Onders said. "Rapid weaning from mechanical ventilation allows for faster rehabilitation-giving patients a better chance of recovery, independence, and a new more normal way of life."
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