Treatment of Severe Heart Failure - AI: FineHeart certified ISO 13485 : 2016 for Medical Device Quality Management Systems
ICOMS FLOWMAKER®, First Fully Implantable Electro-Physiological Cardiac Assistance Device
BORDEAUX, France--(BUSINESS WIRE)--#IcomsFlowMaker--FineHeart S.A, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, a fully Implantable Cardiac Output Management System designed to address the unmet need of patients suffering from severe heart failure, today announced its ISO 13485 : 2016 certification. This certifies the compliance of FineHeart's quality management system with medical device industry regulations and has been issued following an audit by BSI, the independent, internationally recognized, accreditation organization.
“The whole team is extremely proud to have accomplished this crucial step in the development of the ICOMS FLOWMAKER®. The ISO 13485 certification confirms the quality standards that have always prevailed within the company, from the design to the fully in-house production of our breakthrough cardiac assistance device. Our goal is to allow patients suffering from severe heart failure to return to a normal life, thanks to our device for which First In Human trials are scheduled to begin next year," declared Arnaud Mascarell, CEO & co-founder of FineHeart.
“We are delighted to have obtained ISO 13485:2016 certification. This demonstrates FineHeart's ability to produce quality complex medical devices and related services that systematically meet the demands of patient safety and relevant regulatory requirements,” explained Virginie Rivet, FineHeart’s Quality and Regulatory Affairs Director
About FineHeart : http://fineheart.fr/
About the ICOMS FLOWMAKER
The ICOMS FLOWMAKER® is the first fully intraventricular, wireless flow accelerator that provides physiological support synchronized with the heart's natural contractions. It respects the natural blood flow and does not require aortic bypass surgery. It is the first miniaturized device - barely 10 cm in size - that is adjustable to patients' needs, like a pacemaker, to treat patients with varying degrees of severity. It has no external driveline as it is recharged via a wireless transcutaneous energy transfer system (TET). The device is implanted using a minimally invasive beating-heart procedure, commonly performed by cardiac surgeons, which, on average lasts 90 minutes.
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