Synapse Biomedical announced that the FDA granted premarket approval (PMA) to its NeuRx diaphragm pacing system (DPS).
Oberlin, Ohio-based Synapse designed NeuRx DPS for patients with spinal cord injuries who rely on mechanical ventilation. These spinal cord injury patients can utilize this option when they prefer a more natural method of breathing.
Rather than using positive pressure (forced air), NeuRx DPS provides negative pressure ventilation. This mimics the body’s natural breath cycle. The battery-powered device delivers electrical stimulation via four percutaneous intramuscular electrodes. These are implanted into the diaphragm through minimally invasive laparoscopy.
Synapse designed the system for patients with stable spinal cord injuries with stimulatable diaphragms who lack control of the diaphragm. Patients 18 years of age and older can use it to breathe without the assistance of a mechanical ventilator for at least four continuous hours a day. Many go on to use the device for up to 24 hours a day, Synapse said.
Dr. Raymond Onders, chair of surgical innovation at University Hospitals Cleveland Medical Center, pioneered the development. He did so alongside J. Thomas Mortimer, emeritus professor of biomedical engineering at Case Western Reserve University. The first implant of NeuRx DPS came in a prospective clinical investigation in 2000. Since, more than 2,500 patients worldwide — including actor Christopher Reeve — received the implant.
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“Synapse Biomedical is dedicated to helping free people from mechanical ventilators,” said Anthony Ignagni, CEO and founder of Synapse. “We are currently stimulating over 10,000,000 breaths per day for spinal cord injured patients who can’t breathe on their own around the world. With this FDA approval, we can make our diaphragm pacer available to many more patients who were previously unable to access a hospital administering our humanitarian device.”
