Synapse Biomedical has received the US Food and Drug Administration (FDA) premarket approval (PMA) for its NeuRx Diaphragm Pacing System (NeuRx DPS).

The NeuRx DPS is a battery-powered device that delivers electrical stimulation for use in patients with spinal cord injury (SCI) who are dependent on mechanical ventilation.

It is indicated for SCI patients aged 18 years and above to breathe without the assistance of a mechanical ventilator for at least four continuous hours a day.

The PMA allows more hospitals to implement the NeuRx DPS, eliminating a lengthy internal review and approval process, under the previous humanitarian device exemption, said the company.

Synapse Biomedical founder and CEO 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.”

Unlike ventilators, which use positive end-expiratory pressure (PEEP), the NeuRx DPS device provides negative pressure ventilation that simulates the body’s natural breath cycle.

The device is designed to be small in size, with no moving parts, and operate without noise.

It enables diaphragm stimulation for patients through four percutaneous intramuscular electrodes, implanted into the diaphragm with minimally invasive laparoscopy.

According to Synapse, the PermaLoc Electrodes are designed using 316 stainless steel and other biocompatible materials, specifically for long-term implantation into the diaphragm.

The electrical signals to the diaphragm are controlled by NeuRx EPG, a stimulator box that allows the treatment providers to adjust its settings.

NeuRx DPS was first implanted in a clinical investigation in 2000 by University Hospitals Cleveland Medical Centre surgical innovation chair Raymond Ondersand Case Western Reserve University (CWRU) biomedical engineering emeritus professor J Thomas Mortimer.

Raymond Onders said: “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.”