First Fully Implantable, AI-Driven Electro-Physiological Cardiac Assistance Device to Revolutionize Heart Failure Treatment

A new fully implantable cardiac output management system designed to address the unmet need of patients suffering from severe heart failure is the only circulatory assistance device capable of synchronizing with the opening of the aortic valve to increase the native cardiac function with every heartbeat. Besides being totally adaptable, the mini intracardiac pump uses algorithms to recognize the patient’s effort, identify arrhythmias and to adjust the level of assistance provided in real time.

The ICOMS FLOWMAKER developed by FineHeart S.A. (Bordeaux, France) is the world's first and only fully implantable electro-physiological cardiac assistance device for the treatment of severe heart failure. Besides being totally adaptable, the mini intracardiac pump developed by FineHeart is the first fully intraventricular, wireless flow accelerator that provides physiological support synchronized with the heart's natural contractions. It respects the natural blood flow and does not require aortic bypass surgery. It is the first miniaturized device - barely 10 cm in size - that is adjustable to patients' needs, like a pacemaker, to treat patients with varying degrees of severity.

The algorithms used in the ICOMS FLOWMAKER represent the real intelligence of the device. Much like the algorithms used in pacemakers, they allow to recognize the patient’s effort, identify arrhythmias and to adjust the level of assistance provided in real time. The ICOMS FLOWMAKER offers great autonomy to patients with severe heart failure. It requires little energy: its 70 g battery is recharged through the skin via a wireless transcutaneous energy transfer system (TET), avoiding any risk of infection. The device is implanted using a minimally invasive beating-heart procedure, commonly performed by cardiac surgeons, which, on average lasts 90 minutes.

Severe heart failure is the second leading cause of death worldwide after cancer. It is a degenerative disease that progresses to a severe form and results in the inability of the heart to pump normally. Each year 200,000 patients cannot be appropriately treated due to a lack of therapeutic solutions. With its unique features, the ICOMS FLOWMAKER represents an effective therapeutic alternative for all these patients. FineHeart has been granted a patent by the USPTO (United States Patent and Trademark Office) named "Method for managing a heart pump" that covers various therapeutic modes of the ICOMS FLOWMAKER.

“The ICOMS FLOWMAKER started as a vision and resulted in the development of a totally disruptive approach to the treatment of severe heart failure. It is the first smart mini cardiac device that is programmable by the doctor, regardless of the characteristics of the sick heart and the heart rhythm. It preserves and assists the normal function of the heart to optimize the therapeutic effect and help its progression, in a personalized way for each implanted patient,” said Dr. Stéphane Garrigue, CSO Cardiologist and co-Designer of the ICOMS Flowmaker. “This is the first device ever to produce blood flow in strict accordance with cardiac physiology. This enables the heart to increase its chances of spontaneous recovery, and for the patient to avoid vital dependence on cardiac assistance, a major downside of all current cardiac assistance devices. Thanks to its unprecedented functionality, the ICOMS FLOWMAKER brings hope for doctors and thousands of patients suffering from severe heart failure, whose only current therapeutic solution is a transplant.”

“Even if the technologies developed over the last few decades allow patients to recover their vital functions and regain a certain degree of autonomy, there remain limitations and constraints which prevent them from leading a normal life. With the ICOMS FLOWMAKER, our ambition is to enable patients with severe heart failure to return to a normal life,” added Arnaud Mascarell, CEO and co-Founder of Fineheart.

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FineHeart S.A.