Ruling will make device more accessible for those with spinal cord injuries
OBERLIN, Ohio – (April 5, 2023) — Synapse Biomedical, Inc. announced today that the FDA has granted premarket approval (PMA) of the NeuRx® Diaphragm Pacing System (NeuRx DPS®) for use in patients with spinal cord injuries who rely on mechanical ventilation.
PMA is the most stringent type of device marketing application required by FDA. More hospitals are expected 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.
“This is a very big deal for our community,” said Jen French, executive director of the North American Spinal Cord Injury Consortium, an advocacy group. “It will improve access and affordability for people living with spinal cord injuries and give them the chance to live life without the restrictions imposed by a ventilator.”
About the NeuRx DPS®
The NeuRx DPS® is an option for spinal cord injury (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 percutaneous intramuscular electrodes implanted into the diaphragm with minimally invasive laparoscopy. 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 4 continuous hours a day. Many patients have gone on to use the device up to 24 hours per day.
Pioneered by Raymond Onders, MD, Chair of Surgical Innovation at University Hospitals Cleveland Medical Center, and J. Thomas Mortimer, Emeritus Prof. of Biomedical Engineering at Case Western Reserve University (CWRU), NeuRx DPS® was first implanted in a prospective clinical investigation in 2000 and has now been proven in over 2,500 patients worldwide. Actor Christopher Reeve was one of the first recipients.
“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.”
“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.
News that the FDA is making the device more available was welcomed by surgeons who use it. Trauma surgeon Chasen Croft, MD, has been implanting the NeuRx DPS® since 2012 at the University
of Florida Health Science Center. “Nothing is more humbling than witnessing a spinal cord injury patient, whom others have told would never be able to breathe on their own, being liberated from mechanical ventilation. The physiologic benefit and, more importantly, the psychologic improvement afforded patients through spontaneous respiration after diaphragmatic pacer implantation is truly gratifying.”
Andrew Kerwin, MD, Trauma & Surgical Critical Care Division Chief at the University of Tennessee Health Science Center, started implanting the NeuRx DPS® in 2012: “Hospitals and surgeons involved in the care of acute cervical spinal cord injury patients should consider early diaphragm pacing implantation to be an integral part of a comprehensive spinal cord injury care program.”
Integrating diaphragm pacing into standard of care
The FDA approval should change the standard of care in treating SCI injuries, said P. Hunter Peckham, Ph.D., Emeritus Professor of Biomedical Engineering at CWRU, and Co-Director, MetroHealth Rehabilitation Institute, MetroHealth System, a pioneer in neurostimulation and rehabilitation engineering.
“This life-altering technology should bring new freedom to thousands of people with SCI injuries,” he said.
The National Spinal Cord Injury Statistical Center estimates 17,900 new SCI cases each year. Since 2015, 59.8% 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.
Historically, patients were implanted months to years after their catastrophic, life-changing event. Recent studies have shown early treatment with the NeuRx DPS® decreases patient time on mechanical ventilation, reduces hospital length of stay by an average of 19 days, and provides hospitals an average cost savings of $140,000 per patienti. With PMA approval, hospitals now have immediate access to this technology and are able to implement the NeuRx DPS® into their standard of care. This approval also increases patient access to this life-changing technology and provides treatment options in geographical areas that do not have an active implant center.
Patients are encouraged to speak with their healthcare provider to determine if the NeuRx DPS® is right for them. A list of current treatment centers is available here. More information on the safety and efficacy of the NeuRx DPS® can be found in the Summary of Safety and Efficacy Data available at www.fda.gov.
For more information contact Moustapha Diop (COO) at Synapse Biomedical 1-888-767-3770 extension 137 or email firstname.lastname@example.org.
About Synapse Biomedical, Inc.
Founded in 2002, Synapse Biomedical’s mission is to provide life transforming treatments through the commercialization of our neurostimulation platforms. Synapse Biomedical aims to build a sustainable enterprise on the foundation of scientific & clinical findings that will provide meaningful value to patients, employees, community, and shareholders. Synapse is based in Oberlin, Ohio, approximately 30 miles west of Cleveland. For more information, including fact sheets, frequently asked questions, high resolution images and broadcast quality video, please visit www.synapsebiomedical.com.
i Kerwin AJ, Diaz Zuniga Y, Yorkgitis BK, Mull J, Hsu AT, Madbak FG, Ebler DJ, Skarupa DJ, Shiber J, Crandall ML. Diaphragm pacing decreases hospital charges for patients with acute cervical spinal cord injury. Trauma Surg Acute Care Open. 2020 Dec 21;5(1):e000528. doi: 10.1136/tsaco-2020-000528. PMID: 33381653; PMCID: PMC7754627.