BORDEAUX, France — FineHeart, a clinical-stage MedTech company focused on innovative devices for heart failure, has reached a significant milestone in its “First in Human” study. The company has successfully confirmed the proof of concept for its FlowMaker® device, which was implanted in patients with advanced heart failure for the first time without requiring a cardiac arrest procedure. This breakthrough reduces surgical risks and enhances patient recovery.
The FlowMaker® was implanted using a new minimally invasive technique that allows it to work in sync with the heart’s natural contractions. This method optimizes blood flow without needing an external bypass, setting it apart from other devices. The compact design and low energy consumption of the FlowMaker® enable it to be powered wirelessly, marking a major advancement for patients seeking long-term hemodynamic support.
These implantations are part of a European study led by Professor Ivan Netuka, MD, who heads the Department of Cardiovascular Surgery at IKEM in Prague, a leading center for cardiovascular research.
Professor Netuka presented the initial results during a plenary session at the 8th International Summit on Mechanical Circulatory Support organized by the European Association for Cardiac and Thoracic Surgery (EACTS) on November 8, 2024.
The FineHeart Research and Development team expressed gratitude to Professor Netuka for his leadership and contributions to the project.
“This success is the result of close collaboration and commitment from both teams,” they stated.
Arnaud Mascarell, CEO and co-founder of FineHeart, emphasized the importance of this achievement: “This milestone brings us closer to realizing FineHeart’s vision. The promising results provide insights into what we can offer patients with advanced heart failure and pave the way for international multicenter trials to confirm these findings over longer periods.”
Dr. Stéphane Garrigue, MD, PhD, CSO and co-founder of FineHeart, noted that the results from vulnerable patients reaffirmed the potential identified in earlier preclinical studies. “This first stage of the ‘First in Human’ study marks a significant step toward effective wireless therapy that is less invasive and better suited than existing treatments,” he said.
Professor Laurent Barandon, MD, PhD, a cardiac surgeon in Bordeaux and trainer for FlowMaker® implantation, commented on the successful use of surgical tools developed by FineHeart during this pilot study. He highlighted that these tools demonstrated the feasibility of this new minimally invasive procedure. The ability of this fully implantable wireless device to support natural heart function could expand treatment options for many patients with less severe forms of heart disease.
FlowMaker® is designed to be the first implantable cardiac output accelerator that works within the heart’s ventricles. It provides physiological support synchronized with natural heart contractions while respecting normal blood flow without requiring an aortic bypass.
This miniaturized device is only 10 cm long and adapts to patients’ needs like a pacemaker. It recharges wirelessly through a transcutaneous energy transfer system (TET), eliminating external cables and reducing infection risks.
The implantation process is minimally invasive and typically lasts about 90 minutes. FlowMaker® represents an effective alternative for over 200,000 patients annually suffering from severe heart failure who currently lack adequate treatment options.
FineHeart’s advancements could significantly change how advanced heart failure is treated, offering hope to many patients who need innovative solutions.
Related topics:
- New X-ray Imaging Technique Aids Early Detection of Heart Disease Risk
- Heart Foundation Applauds Funding for Heart Failure Treatment
- Study Reveals Genetic Links Between Osteoarthritis And Cardiovascular Disease