First Report of TransAeris® Diaphragm Pacer (DP) in High Risk Cardiac Surgeries under FDA Emergency Use Authorization
OBERLIN, Ohio, Oct. 1, 2020 /PRNewswire/ — Synapse Biomedical, Inc®. (www.synapsebiomedical.com) announced today that surgeons at University Hospitals Cleveland Medical Center have improved the prognosis of several cardiac patients after the use of TransAeris DP for the prevention and treatment of Ventilator Induced Diaphragm Dysfunction (VIDD). Dr. Raymond Onders presented the abstract detailing these findings at the 17th Annual Perioperative and Critical Care Conference.
Synapse Biomedical Inc received authorization for the use of TransAeris DP under the FDA’s Emergency Use Authorization in April of 2020, to assist patients weaning from MV. TransAeris DP functions with temporary electrodes implanted either at the time of surgery, or by an additional minimally invasive procedure, to stimulate the diaphragm.
Patients with known risk factors for post-operative prolonged MV, such as unilateral diaphragm dysfunction and on MV pre-urgent median sternotomy, were identified for implantation. These patients all underwent extensive cardiac surgery, and range in age from 24 to 72 years old. Once in the intensive care unit, stimulation began generating a fused diaphragm contraction preventing diaphragm atrophy and Ventilator Induced Diaphragm Dysfunction (VIDD). The patients were extubated in 6.7 hours on average, a short period of time given their operation and other medical conditions. No patient was re-intubated or developed any respiratory complications. All temporary electrodes were removed completely, and all patients were discharged within 9 days post operatively. In this small series TransAeris DP positively affected diaphragm function and ventilation. In unilateral dysfunction, DP helped the known paradoxical diaphragm movement and associated sleep dysfunction.
These findings are important because prolonged ventilation and intubation after cardiac surgery is an important complication which can lead to other problems. Continued experience with DP can help enhance the recovery and weaning from a ventilator after cardiac surgery. These findings are even more important during this pandemic, since the TransAeris system could reduce ventilator burden in COVID-19 patients by a significant amount. This could lead to more ventilators being available in a time of great demand, creating a better environment for other patients in need.
“The ability to decrease the need for mechanical ventilation frees up more ventilator units,” said Raymond Onders, MD, Chief of General and Gastrointestinal Surgery and the Remen Chair in Surgical Innovation at UH and Professor of Surgery at CWRU. “For these patients not only was this technology more efficient in weaning from the ventilator but it also decreased the complications from the ventilator. During the COVID-19 pandemic, we know it is important for all patients to reduce the amount of time they are on ventilators and this technology can potentially help.”
“It is gratifying to see these positive initial results in these high-risk cardiac surgery patients,” said Anthony R. Ignagni, President & CEO of Synapse Biomedical. “Anyone who has been on, or has had a loved one on, invasive mechanical ventilation knows that reducing the stress of intubation by reducing the time on the ventilator can be a substantial psychological improvement for the patient as well as reducing risks and costs.”
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.
