FineHeart announced French regulators gave it the green light to initiate a first-in-human heart device trial in France.
The French National Agency for the Safety of Medicines and Health Products (ANSM) authorized a prospective, non-randomized study designed to assess the safety, implant feasibility and preliminary clinical performance of the Bordeaux-based company’s FlowMaker device for patients with advanced heart failure.
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First-in-human implants in France follow the first successful implantations carried out in 2024, according to a news release. Those took place at IKEM (Institute for Clinical and Experimental Medicine) in Prague.
FineHeart says its study marks a significant step in the clinical development of its FlowMaker device, with investigators set to use the device in several French centers specializing in cardiac surgery.
FlowMaker, a next-generation, fully implantable left ventricular assist device (LVAD), works in synergy with the heart’s natural contraction. FineHeart labeled the device as less invasive than current devices. The market is led by Abbott’s HeartMate, while other companies like CorWave and BrioHealth are making entries as well.
According to FineHeart, its technology aims to preserve native cardiac function while significantly improving quality of life.
“ANSM approval marks a key strategic step for FineHeart,” said Arnaud Mascarell, CEO and co-founder of FineHeart. “It validates the quality and solidity of our preclinical work and confirms the relevance of our initial clinical results.
“This 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.”
