FineHeart has received the French National Agency for the Safety of Medicines and Health Products (ANSM) authorisation to begin the first-in-human study of FlowMaker in France.
The prospective, non-randomised study is designed to evaluate the safety, implant feasibility, and preliminary clinical performance of the FlowMaker device.
FlowMaker is a next-generation, fully implantable left ventricular assist device designed to enhance cardiac output in patients with advanced heart failure.
The clinical trial follows initial successful implantations, conducted at the Institute for Clinical and Experimental Medicine in Prague, last year.
FineHeart will conduct the first-in-human clinical study of FlowMaker in multiple French centres specialising in cardiac surgery.
French clinical trial principal investigator Pascal Leprince said: “The launch of this trial in France represents a highly promising step forward for patients with advanced heart failure.
“Thanks to its pulsatile operation, synchronised with the heart’s electrical activity, the FlowMaker could transform the treatment of these patients, offering them a less invasive and potentially more durable solution than current devices.
“We look forward to starting this clinical study and confirming these benefits.”
FlowMaker is a less invasive device that works in harmony with the heart’s natural contractions to preserve native cardiac function while enhancing patients’ quality of life.
Designed by French electrophysiologists and rhythmologists, the device assists the heart, adapts to disease progression, and can be removed without significant risk.
It is fully intraventricular, providing physiological support synchronised with natural heart contractions, and does not require an aortic bypass.
FlowMaker operates with minimal energy consumption and eliminates the need for a percutaneous connection to external batteries.
It is recharged through a transcutaneous energy transfer system, reducing infection risk and further enhancing patient quality of life.
The device, implanted through a minimally invasive procedure on a beating heart that typically lasts 90 minutes, provides an alternative for heart failure patients.
FineHeart CEO and co-founder 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.
“The 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.”
