FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France
Patients with advanced heart failure will be treated with FlowMaker®, an innovative, fully implantable device for restoring cardiac output.
BORDEAUX, France–(BUSINESS WIRE)–FineHeart S.A., a clinical-stage medical technology company specializing in the development of innovative solutions for cardiology, announces that it has received authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM) to initiate its First-In-Human (FIH) clinical trial in France.
This prospective, non-randomized study is designed to assess the safety, implant feasibility and preliminary clinical performance of the FlowMaker® device in patients with advanced heart failure. It follows the first successful implantations carried out in 2024 at IKEM (Institute for Clinical and Experimental Medicine) in Prague, whose initial results have been presented at several international scientific congresses.
