Business Wire

Synapse Biomedical Inc. Receives CE Approval for TransAeris, the First Medical Device Approved for the Treatment of Ventilator Induced Diaphragm Dysfunction (VIDD)

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Synapse Biomedical (www.synapsebiomedical.com), an innovator in neurostimulation and manufacturer of the NeuRx Diaphragm Pacing System®, announced today, the CE Mark approval for the TransAeris™ System. TransAeris is a temporary diaphragm stimulator, for use in intensive care unit (ICU) patients on mechanical ventilation (MV). While MV provides life sustaining respiration, side effects of prolonged MV include diaphragm atrophy and dysfunction, which is referred to as ventilator-induced diaphragm dysfunction (VIDD). A primary contributor to extending ICU ventilator weaning times, VIDD increases health care costs and greatly increases patient morbidity and mortality. Building on more than 25 years of diaphragm pacing research and practical experience with their respiratory assist device for Spinal Cord Injury & Lou Gehrig’s Disease SCI & ALS, Synapse is pleased to introduce the TransAeris device, which is now available in Europe and select international markets. “We are excited to leverage our use of the NeuRx platform, and experience with thousands of patients, to this new group of ICU patients. This is the first device to treat VIDD and with TransAeris we hope to help many patients avoid the costs and complications that come with prolonged mechanical ventilation,” said Anthony R. Ignagni, President & CEO of Synapse.

About TransAeris technology

The TransAeris™ System is a temporary percutaneous intramuscular diaphragm stimulator intended for patients at risk of or on prolonged positive pressure mechanical ventilation. TransAeris is indicated for use in the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD). TransAeris is used to provide neuromuscular electrical stimulation to the diaphragm while the patient is on mechanical ventilation to prevent, slow, or reverse diaphragm disuse atrophy and, more generally, to treat VIDD. Once the patient is successfully extubated after mechanical ventilation, the electrodes are removed from the patient.

About Synapse Biomedical, Inc.

Founded in 2002, 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.

Contact information

Synapse Biomedical Europe
Moustapha Diop, +33 (0)6 11 67 53 46
COO & Managing Director
mdiop@synapsebiomedical.com

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