Latest news with #FIH
Yahoo
2 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
Associated Press
2 days ago
- Business
- Associated Press
FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France
BORDEAUX, France--(BUSINESS WIRE)--Jun 3, 2025-- 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.'1ANSM: French National Agency for the Safety of Medicines and Health Products About FineHeart -FineHeart View source version on CONTACT: Europe Media Relations Annie-Florence Loyer [email protected] +33 (6) 88 20 35 59FineHeart Communications James Palmer [email protected] +33 (0) 7 60 92 77 72 KEYWORD: EUROPE CZECH REPUBLIC FRANCE INDUSTRY KEYWORD: MEDICAL DEVICES OTHER HEALTH HEALTH CLINICAL TRIALS CARDIOLOGY SOURCE: FineHeart S.A. Copyright Business Wire 2025. PUB: 06/03/2025 07:01 AM/DISC: 06/03/2025 07:01 AM
Business Wire
2 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
The Star
25-05-2025
- Sport
- The Star
Malaysia to host more hockey tournaments after thumbs-up from FIH
PETALING JAYA: Malaysia will be hosting more international hockey tournaments as encouragements come from the International Hockey Federation (FIH). Malaysian Hockey Confederation (MHC) president Datuk Seri Subahan Kamal said the world governing body have been urging them to host more international tournaments as the Nations Cup is set to take place in Kuala Lumpur from June 15-21.
Hans India
19-05-2025
- Sport
- Hans India
FIH Pro League: Indian team ready for tough matches in Europe, says Harendra
With the second half of the FIH Hockey Pro League 2024-25 fast approaching, Harendra Singh, head coach of the Indian women's hockey team, is charting the course for his team currently situated in sixth place on the points table. According to Harendra, the Indian team did reasonably well in the home leg of the FIH Pro League and is getting ready to take on some tough opponents in Europe. "The upcoming matches of the FIH Hockey Pro League in Europe will see the Indian women's hockey team play some tough opponents, and the team is definitely ready for it. When we go into the FIH Hockey Pro League in Europe, it will be after our tour of Australia, which is a great form of preparation, because match-practice and game time are both very valuable and will always benefit any team," Harendra told the FIH in an interview in the buildup for the next stage in the Pro League. Harendra said his players will benefit from the experience of playing in the home leg of the Pro League, which included a massive shootout win against World No.1 and Olympic champion Netherlands. "The team did well in the home leg, especially the shootout win against the Netherlands was a massive confidence booster for the team. And as we go into the European leg, the experience and knowledge from the previous phase will definitely benefit the team. We will be playing across three different venues in London, Antwerp and Berlin during this time, and the team is working hard. With India set to play Australia, Argentina, Belgium and China in the Pro League, Harendra said going into the league, soon after a tour of Australia, would hold his team in good stead. "Coming from the Australian tour and straight into the FIH Pro League is surely going to be beneficial, but the games in Europe will also be very different in every sense of it. "Australia, Argentina, Belgium and China are all good teams and we aren't taking anything for granted, no matter what the situation is. Our preparations for the FIH Hockey Pro League are moving along at a good pace and we will continue to work towards our goals," said Harendra. The India women's team coach will have to improve its position in the league and remain in the elite competition. The team has lost a lot of steam after the high of the Tokyo Olympic Games in 2010 and remaining in the FIH Pro League will help them get more matches against top opponents in future and get back to where they were.
