Heart failure

Treatment of Severe Heart Failure – IA: FineHeart Certified ISO 13485:2016 for Medical Device Quality Management Systems

BORDEAUX, France–(BUSINESS WIRE)–FineHeart SA, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, a fully implantable cardiac output management system designed to address the unmet needs of patients with severe heart failure, announced today now has ISO 13485:2016 certification. This certifies compliance of FineHeart’s quality management system with medical device industry regulations and was issued following an audit by BSI, the certification body. independent and internationally recognized accreditation.

“The whole team is extremely proud to have accomplished this crucial step in the development of the ICOMS FLOWMAKER®. ISO 13485 certification confirms the quality standards that have always prevailed within the company, from the design to the entirely in-house production of our revolutionary cardiac assist device. Our goal is to allow patients suffering from severe heart failure to return to a normal life, thanks to our device whose First In Human trials are due to begin next year,” said Arnaud Mascarell, CEO & co-founder of FineHeart.

“We are delighted to have achieved ISO 13485:2016 certification. This demonstrates FineHeart’s ability to produce quality complex medical devices and associated services that consistently meet patient safety requirements and relevant regulatory requirements,” explained Virginie. Rivet, Director of Quality and Regulatory Affairs of FineHeart

About FineHeart: http://fineheart.fr/


The ICOMS FLOWMAKER® is the first completely intraventricular wireless flow accelerator that provides physiological support synchronized with the natural contractions of the heart. It respects the natural blood flow and does not require an aortic bypass. This is the first miniaturized device – barely 10 cm – which adapts to the needs of patients, like a pacemaker, to treat more or less severe patients. It has no external transmission as it is recharged through a wireless transcutaneous energy transfer (TET) system. The device is implanted using a minimally invasive beating-heart procedure, commonly performed by cardiac surgeons, which takes an average of 90 minutes.