Synapse Biomedical has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for its NeuRxDiaphragm Pacing System (NeuRx DPS) to treat patients with spinal cord injuries who depend on mechanical ventilation.
The NeuRx DPS battery-powered device is an intramuscular, percutaneous, motor point diaphragm stimulation system.
It offers electrical stimulation through four percutaneous intramuscular electrodes that are implanted directly into the diaphragm using minimally invasive laparoscopy.
Synapse Biomedical CEO and founder Anthony Ignagni said: “Synapse Biomedical is dedicated to helping free people from mechanical ventilators. 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.”
The device is suitable for use in patients with stable spinal cord injury (SCI) with stimulable diaphragms, but who don’t have control of their diaphragms.
NeuRx DPS can be used to help patients aged 18 years and above to breathe without a mechanical ventilator for at least four continuous hours a day.
First implanted in a prospective clinical investigation in 2000, the device has currently benefitted more than 2,500 patients across the world.
The PMA approval enables hospitals to implement the NeuRx DPS system into their standard of care.
In addition, it is expected to enhance patient access to the battery-powered device besides serving as a treatment option in geographical areas that lack an active implant centre.
Early treatment with the NeuRx DPS shortens patient time on mechanical ventilation and decreases hospitalisation time by an average of 19 days, according to data from recent studies.