The Latest Cardiac and Vascular News
BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A., a clinical-stage medtech company developing breakthrough solutions for cardiology, announces the extension of its ISO 13485:2016 certification to cover all processes related to the production of its fully implantable cardiac assist device, the FlowMaker®. Issued following an audit conducted by BSI, an independent notified body of […]
BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A, a clinical-stage medtech company developing breakthrough solutions for cardiology, is pleased to announce the appointment of André-Jacques Auberton-Hervé to its Board of Directors. “The exceptional career of André-Jacques, a visionary industrialist, is inspirational for the whole team. We sincerely thank him for the trust he has […]
BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A, a medical device company developing innovative devices for cardiology announced today that it has received authorization from the SUKL (the Czech Republic State Institute for the Control of Medicinal Products) to carry out “A prospective, single arm, single center, First in Human Study to evaluate the […]
Extending the intellectual property of its fully implantable medical device for restoring cardiac output (ICOMS) BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A, a medical device company developing the FLOWMAKER®, a fully implantable cardiac output restoration system (ICOMS) to address the unmet needs of patients suffering from severe heart failure, announced today that its first […]
ICOMS FLOWMAKER®, First Fully Implantable Electro-Physiological Cardiac Assistance Device Guillaume Buc, Chief Technical Officer Sophie Jonquière, Chief Procurement & Supply Chain Officer BORDEAUX, France–(BUSINESS WIRE)–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 […]
ICOMS FLOWMAKER®, First Fully Implantable Electro-Physiological Cardiac Assistance Device September 07, 2022 08:44 AM Eastern Daylight Time BORDEAUX, France–(BUSINESS WIRE)–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, […]
€6 million of further funds raised in addition to the €15 million in June Clinical trials expected in 2022 BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, an Implantable Cardiac Output Management System designed to address the unmet need of patients suffering from […]
The First In Human implantation of the ICOMS FLOWMAKER® is assured following this financing BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A, a preclinical medical device company that has developed the ICOMS FLOWMAKER®, an Implantable Cardiac Output Management System designed to address the unmet need of patients suffering from severe heart failure, today announced the […]
Towards a new standard for device indication: Implantation for temporary or permanent use Easy removal with a beating heart without damage to the myocardium 30 days after implantation Normal heart functioning 60 days after explantation Completely sealed operation with dedicated implant fixation system Quick recovery and short hospital stay Autonomy […]
A major step and a critical milestone achieved prior to First In Human clinical trials FineHeart’s TET is a system with no percutaneous driveline that transfers energy through the skin to charge the ICOMS pump battery TET is rapidly implantable (less than 15 mins) and will give patients autonomy The […]
