OBERLIN, Ohio–(BUSINESS WIRE)– Synapse Biomedical (www.synapsebiomedical.com), vernieuwer van neurostimulatie en fabrikant van het NeuRx Diaphragm Pacing System®, heeft een CE-markering gekregen voor het TransAeris™ System. TransAeris is een tijdelijke stimulator voor het middenrif voor patiënten op de intensive care die aan de beademing zitten. Hoewel beademing vitale ademhaling mogelijk maakt, heeft de behandeling atrofie en functiestoornissen aan het middenrif als bij-effecten. Deze bijwerkingen worden ook wel onder de afkorting VIDD (ventilator-induced diaphragm dysfunction) geschaard. Doordat VIDD er in grote mate aan bijdraagt dat patiënten langer op de IC liggen, vergroot dit zorgkosten en verhoogt de aandoening de morbiditeit en mortaliteit onder patiënten. Synapse introduceert daarom met blijdschap de TransAeris, die nu beschikbaar is in Europa en bepaalde internationale markten. Daarvoor steunde het bedrijf op meer dan 25 jaar aan onderzoek naar middenrifpacing en praktische ervaring met zijn apparaat voor ademhalingsondersteuning bij rugwervelblessures en ALS.

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

OBERLIN, Ohio–(BUSINESS WIRE)– 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.

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Contacts

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