FDA Grants Breakthrough Designation to Synapse Biomedical’s TransAeris® System

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

How To Control a Radio Frequency (RF) Process

The radio frequency welding and manufacturing process uses electromagnetic energy and pressure to fuse and permanently bond vinyl, thermoplastic, and coated materials to produce a specific product - all according to customer requirements. Using this RF sealing process, a distinct, one-piece perpetual bond is formulated that is both solid and resistant to ripping or tearing. But how is this process controlled, and with what specific tools? Read on.

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.

TransAeris system 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.  “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.

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.