This study confirms the ICOMS FLOWMAKER’s ability to support cardiac function without any heart alteration after being implanted for 30 days. The device’s unique fixation system allows for easy removal performed on a beating heart, unchanged blood flow, and without trauma to the myocardium. The locking ring of the fixation system is intended to remain in place upon explantation, sidestepping additional cutting or grafts to the heart. Once the device was removed, a fully sealed occluder was introduced, and after 60 days, no structural, histological, or embolic tissue damage occured. This pioneering technique highlights FineHeart’s technology’s ability to adapt and support shorter surgical cardiac procedures for ventricular assist devices.
“After demonstrating the ease of implantation of the ICOMS FLOWMAKER®, we are very proud to show the ease of removal of the device 30 days after implantation, with post-op recovery in less than 48 hours, and more than 60 days totally free of cardiac assistance, without any structural damage to the heart,” said Arnaud Mascarell, CEO and co-Founder of FineHeart. “This operation to remove a cardiac assistance device with a beating heart is a world first. These results underpin the confidence of the medical community in our approach to treat patients suffering from severe heart failure. They will be able to avoid lengthy hospitalization that is often fraught with major complications. This achievement, allows for the use of the ICOMS FLOWMAKER® either as temporary or permanent treatment depending on the severity of the pathology, paves the way for the First implantation in Human.”
“The ability to implant with minimally invasive surgery and subsequently explant the ICOMS FLOWMAKER® paves the way for progress in facilitating hemodynamic ventricular unloading and consequent myocardial recovery. Once clinically proven, this can be a potentially disruptive step forward in the treatment of advanced heart failure,” said Harvard Medical School Professor Mandeep R. Mehra, MD, the William Harvey Distinguished Chair in Cardiovascular Medicine at Brigham and Women’s Hospital, Boston, and FineHeart scientific advisory board member.