Synapse Biomedical, Inc®. announced today that the FDA has granted Breakthrough Therapy Device designation to TransAeris®, a temporary percutaneous intramuscular diaphragm stimulator designed to aid in weaning from mechanical ventilation.
| OBERLIN, Ohio, July 21, 2021 /PRNewswire/ -- Synapse Biomedical, Inc®. (www.synapsebiomedical.com) announced today that the FDA has granted Breakthrough Therapy Device designation to TransAeris®, a temporary percutaneous intramuscular diaphragm stimulator designed to aid in weaning from mechanical ventilation.
TransAeris is a temporary percutaneous intramuscular diaphragm stimulator intended for patients identified with a risk of prolonged mechanical ventilation: undergoing high-risk open cardiac surgery, lung transplant, thoracoabdominal aortic aneurysm surgical procedures or in patients that have already failed to wean and have been on mechanical ventilation for 96 or more hours, to prevent or treat ventilator induced diaphragm dysfunction (VIDD). Diaphragm Pacing may enhance recovery after surgery in patients at risk or on prolonged mechanical ventilation. The FDA’s Breakthrough Therapy Device Program creates a path for innovators to get their medical devices to market faster. The program targets novel devices that have the potential to provide patients with a more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases and conditions. This program provides patients and health care providers with timely access to these medical devices by expediting medical devices development, assessment, and review, while preserving the statutory standards consistent with the FDA’s mission to protect and promote public health. “The Breakthrough Device designation for our TransAeris temporary diaphragm stimulation system is built upon our 20-year experience with NeuRx diaphragm pacing,” said Anthony Ignagni, President & CEO of Synapse Biomedical. “We have seen increasing early use of our NeuRx device in spinal cord injured patients and, coupled with the use of our TransAeris system over this past year intended to help ICU patients get off mechanical ventilation earlier under the Emergency Use Authorization program, we hope the mounting evidence and this designation along with our ongoing clinical studies will help move the TransAeris device along the path for quicker approval.” TransAeris builds on the success of another Synapse Biomedical technology, the NeuRx® Diaphragm Pacing Stimulation (NeuRx DPS) System, which has been FDA and CE Mark approved since 2008 for people with Spinal Cord Injury (SCI) and has successfully reduced or eliminated the need for mechanical ventilation. TransAeris was created to assist patients with prolonged mechanical ventilation on a temporary basis up to 30 days, simplifying the external features of the NeuRx DPS system and distilling them into a single patient, 30-day use, disposable device. Since receiving CE mark in Europe for TransAeris, several centers in Europe and the Middle East, including BGU Murnau (Germany), have also used TransAeris successfully in acute spinal cord injury and polytrauma patients. About Synapse Biomedical, Inc.: Founded in 2002, as a spinout from Case Western Reserve University and University Hospitals of Cleveland, Synapse Biomedical’s mission is to provide life transforming treatments through the commercialization of neurostimulation platforms and build a sustainable enterprise on the foundation of scientific & clinical findings that will provide meaningful value to patients, employees, community, and shareholders. Synapse is headquartered in Oberlin, Ohio and has a European Office in Enghien les Bains, France. For more information, please visit www.synapsebiomedical.com. The TransAeris® Diaphragm Pacing System (DPS) has neither been cleared or approved for the indication to assist in weaning patients off ventilators in healthcare settings during the COVID-19 pandemic. TransAeris DPS has been authorized for the above emergency use by the FDA under an EUA. TransAeris DPS has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the TransAeris DPS under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
SOURCE Synapse Biomedical, Inc. |
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