The French National Agency for the Safety of Medicines and Health Products (ANSM) has authorised FineHeart to commence a nonrandomised first-in-human trial in the country to assess the FlowMaker device in heart failure patients.
This prospective trial aims to evaluate the feasibility of device implantation alongside its preliminary clinical performance and safety.
It comes after the initial implantations of the device at the Institute for Clinical and Experimental Medicine in Prague, Czech Republic, last year.
The latest trial will be carried out across several cardiac surgery-specialising centres in France.
According to the company, the fully implantable left ventricular assist device operates in synergy with the natural contraction of the heart.
It is less invasive than current devices and is designed to enhance an individual鈥檚 quality of life by preserving native cardiac function.
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By GlobalDataDesigned by French rhythmologists and electrophysiologists, the device claims to be the first implantable cardiac output accelerator.
It adapts to the pathology’s progression and can be removed with no risk to the patient. It does not necessitate aortic bypass.
The device utilises less energy and operates without percutaneous connections to external batteries, as it is recharged through a transcutaneous energy transfer system, aiding in the elimination of infection risks.
The implantation procedure is performed on a beating heart and typically lasts around 90 minutes.
FineHeart said that the device offers a therapeutic option for over 200,000 individuals annually with advanced heart failure and those who are ineligible for existing treatments.
FineHeart co-founder and CEO Arnaud Mascarell said: “ANSM approval marks a key strategic step for FineHeart. It validates the quality and solidity of our preclinical work and confirms the relevance of our initial clinical results.
鈥淭his green light paves the way for the acceleration of our clinical roadmap, with the ambition of responding to a major unmet medical need. It also sends a strong signal to the entire medtech ecosystem, and to all our partners and investors, whom we thank for their confidence.鈥�
In 2023, the company secured two patents from the China National Intellectual Property Administration for FlowMaker.
