Synapse receives FDA approval for its NeuRx DPS to treat patients with stable SCI
pharmafile | April 6, 2023 | News story | Research and Development |
Synapse Biomedical has announced that it has gained premarket approval (PMA) from the FDA for its NeuRxDiaphragm Pacing System (NeuRx DPS) which is intended to treat patients with spinal cord injuries who currently depend on mechanical ventilation. The device can be used to treat patients over the age of 18.
The device is battery-powered and works as an intramuscular, percutaneous, motor point diaphragm stimulation system, offering electrical stimulation through four percutaneous intramuscular electrodes implanted into the diaphragm using a minimally invasive laparoscopy.
The device can be used to treat patients who suffer from stable spinal cord injury (SCI) with stimulable diaphragms, who cannot control their diaphragms on their own, helping patients to breath without a mechanical ventilator for at least four continuous hours per day.
Dr Raymond Onders, MD, chair of surgical innovation at University Hospitals Cleveland Medical Center, commented: “The new FDA approval is great news for patients. 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 – while significantly reducing costs, freeing up ICU beds and reducing clinical staff time with these patients.”
Anthony Ignagni, chief executive officer and founder of Synapse Biomedical, added: “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.”
Betsy Goodfellow
