Latest news with #ArnaudMascarell
Yahoo
5 days ago
- Business
- Yahoo
French ANSM authorises FineHeart's device trial for heart failure
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's quality of life by preserving native cardiac function. Designed 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. '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.' In 2023, the company secured two patents from the China National Intellectual Property Administration for FlowMaker. "French ANSM authorises FineHeart's device trial for heart failure" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
6 days ago
- Business
- Yahoo
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, June 03, 2025--(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. Conducted in several French centers specializing in cardiac surgery, this study represents a decisive step in the clinical development of FlowMaker®. FlowMaker® is a new-generation, fully implantable left ventricular assist device designed to work in synergy with the heart's natural contraction. Less invasive than current devices, this technology aims to preserve native cardiac function while significantly improving patients' quality of life. Pr Pascal Leprince, Head of the Thoracic and Cardiovascular Surgery Department at Hôpital Universitaire Pitié-Salpêtrière (AP-HP) Sorbonne Université and principal investigator of the clinical trial in France, commented: "The launch of this trial in France represents a highly promising step forward for patients with advanced heart failure. Thanks to its pulsatile operation, synchronized 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." "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. 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" says Arnaud Mascarell, CEO and co-founder of FineHeart. 1 ANSM: French National Agency for the Safety of Medicines and Health Products About FineHeart - FineHeart View source version on Contacts Europe Media RelationsAnnie-Florence Loyerafloyer@ +33 (6) 88 20 35 59 FineHeart Communications James +33 (0) 7 60 92 77 72
Business Wire
6 days ago
- Business
- Business Wire
FineHeart Receives ANSM 1 Authorization to Deploy Its First-In-Human Clinical Study in France
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. Conducted in several French centers specializing in cardiac surgery, this study represents a decisive step in the clinical development of FlowMaker®. FlowMaker® is a new-generation, fully implantable left ventricular assist device designed to work in synergy with the heart's natural contraction. Less invasive than current devices, this technology aims to preserve native cardiac function while significantly improving patients' quality of life. Pr Pascal Leprince, Head of the Thoracic and Cardiovascular Surgery Department at Hôpital Universitaire Pitié-Salpêtrière (AP-HP) Sorbonne Université and principal investigator of the clinical trial in France, commented: " The launch of this trial in France represents a highly promising step forward for patients with advanced heart failure. Thanks to its pulsatile operation, synchronized 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." "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. 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" says Arnaud Mascarell, CEO and co-founder of FineHeart. About FineHeart - FineHeart
