Diaphragm Pacing System Pioneered at UH and CWRU Receives FDA Approval

CLEVELAND – A medical device pioneered by University Hospitals (UH) and Case Western Reserve University has received FDA premarket approval, which opens up its use for many more patients across the nation.

Synapse Biomedical, Inc., announced April 5 the FDA granted premarket approval for its NeuRx® Diaphragm Pacing System (NeuRx DPS®) for use in patients with spinal cord injuries who rely on mechanical ventilation. The company expects more hospitals to begin implementing the NeuRx DPS® now that they no longer have to undergo the lengthy internal review and approval process required under the previous humanitarian device exemption.

NeuRx DPS® was pioneered by Raymond Onders, MD, Chair of Surgical Innovation at UH Cleveland Medical Center, and J. Thomas Mortimer, Emeritus Professor of Biomedical Engineering at CWRU.

NeuRx DPS® was first implanted at University Hospitals in a prospective clinical investigation in 2000 and has now been proven effective in over 2,500 patients worldwide.

The device gained national attention in 2003 when Dr. Onders implanted the system at UH in actor Christopher Reeve, well known for playing Superman in the movies. Reeve had suffered traumatic spinal cord injury (SCI) from a horse-riding accident.

“The new FDA approval is great news for patients,” said Dr. Onders. “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.”

According to Dr. Onders, UH has done more NeuRx DPS® implants than any other site in the world, and that many patients travel from around the nation and the world to UH for the surgery.

NeuRx DPS® is an option for SCI patients who prefer a more natural method of breathing. Rather than using positive pressure (forced air), NeuRx DPS® provides negative pressure ventilation, which mimics the body’s natural breath cycle.

The NeuRx DPS® is a battery-powered device that delivers electrical stimulation via four electrodes implanted through the skin into the diaphragm (breathing muscle) with minimally invasive surgery. It is intended for use in patients with stable SCI with stimulatable diaphragms, but who lack control of their diaphragms.

The device is indicated to allow patients 18 years and older to breathe without the assistance of a mechanical ventilator for at least four continuous hours a day. Many patients have gone on to use the device up to 24 hours per day.

"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," said Anthony Ignagni, CEO and founder of Synapse Biomedical.

The National Spinal Cord Injury Statistical Center estimates 17,900 new SCI cases each year. Since 2015, 59.8 percent of these patients have complete or incomplete tetraplegia, or paralysis of all four limbs, which will require some level of long-term or temporary mechanical ventilation.

Intubation for mechanical ventilation often occurs at the time of injury to manage respiratory failure or to protect the airway in cases of complete SCI between vertebrae C1 and C5. By contrast, in cases of incomplete injuries lower than C5, where the airway is not immediately compromised or at risk, ventilation is often still initiated approximately four days after injury when levels of carbon dioxide rise in the blood due to difficulty expiring, according to a Synapse Biomedical news release.