FDA grants premarket approval to diaphragm pacing system

Synapse Biomedical has received premarket approval from the FDA for its NeuRx Diaphragm Pacing System, which aids adults with spinal cord injuries that require ventilation to breathe, according to a company press release.

Using negative pressure ventilation, as opposed to positive pressure, the NeuRx device can imitate natural breathing and be used continuously for a minimum of 4 hours daily, according to the release.

Patients who want this treatment option must undergo implantation of four percutaneous intramuscular electrodes into their diaphragm, so the device can send electrical stimulation to help them breathe without a ventilator. As Healio previously reported in 2014, the device helped 72% patients become ventilator free, and the release notes that now more than 2,500 patients have received the device and seen benefits.

According to the release, benefits such as shorter mechanical ventilation duration, an average of nearly 20 less days in the hospital and hospital savings of $140,000 for each patient, come when NeuRx is used early.

Now that the device has received premarket approval, Synapse Biomedical anticipates that NeuRx will be widely available in hospitals and become a part of standard care for patients with spinal cord injuries.

“Synapse Biomedical is dedicated to helping free people from mechanical ventilators,” Anthony Ignagni, Synapse Biomedical’s CEO and founder, said in the release. “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.”