The French National Agency for the Safety of Medicines and Health Products (ANSM) has authorized FineHeart to begin a first-in-human clinical trial of its FlowMaker device for patients with heart failure.
This nonrandomised, prospective trial will assess the feasibility, preliminary clinical performance, and safety of implanting the device. The study will take place across several cardiac surgery centers in France.
The FlowMaker device was first implanted in patients last year at the Institute for Clinical and Experimental Medicine in Prague, Czech Republic.
According to FineHeart, the fully implantable left ventricular assist device works in sync with the heart’s natural contractions. It is less invasive than current devices and aims to improve patients’ quality of life by preserving the heart’s native function.
Designed by French rhythmologists and electrophysiologists, the FlowMaker is described as the first implantable cardiac output accelerator. It adapts as the patient’s condition progresses and can be safely removed if needed. The device does not require an aortic bypass.
The device uses less energy and operates without external wires or batteries. Instead, it is recharged through a transcutaneous energy transfer system, which reduces infection risks. The implantation procedure is performed on a beating heart and usually takes about 90 minutes.
FineHeart said the FlowMaker could provide a new treatment option for more than 200,000 people annually with advanced heart failure who are not eligible for current therapies.
FineHeart co-founder and CEO Arnaud Mascarell called the ANSM approval a “key strategic step” that confirms the strength of their preclinical research and early clinical results.
“This green light accelerates our clinical plans and addresses a major unmet medical need,” Mascarell said. “It also sends a strong message to the medtech community, our partners, and investors, whom we thank for their trust.”
In 2023, FineHeart secured two patents for the FlowMaker from China’s National Intellectual Property Administration.
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