FineHeart

ICOMS

FLOWMAKER®

by FineHeart, a breakthrough innovation

A hybrid between a pacemaker and a cardiac assist device, ICOMS FLOWMAKER® is the first definitive therapeutic solution capable of helping the heart restore its natural rhythm.

ICOMS FLOWMAKER®,

a game-changing device

Laurent Barandon, MD
Professor of Cardiac Surgery at the University of Bordeaux, member of the FineHeart Scientific Advisory Board

The technology’s unique ability to support the natural functioning of the heart, without the classic and dreaded complications of current LVAD*, addresses a significant unmet clinical need and could improve the quality of life for hundreds of thousands of patients with advanced heart failure.

*Left Ventricular Assist Device

FineHeart’s ICOMS FLOWMAKER® Implantable Cardiac Output Management System is the first fully implantable, intelligent, wireless, rechargeable device capable of restoring normal blood flow while synchronized to the heart’s natural contractions. It is the only temporary or permanent pump entirely implanted in the left ventricle.. It has no percutaneous driveline as it is recharged via a wireless transcutaneous energy transfer system (TET). ICOMS FLOWMAKER® is adjustable to the severity of different patients’ heart conditions.

Stephane GARRIGUE, MD, Phd, CSO, Co-Fondateur
Inventor of icoms & Interventional cardiologist and cardiac surgeon at the St. Augustine clinic

The latest developments and designs for manufacturing are in progress

All production partners have been certified

FineHeart will work with Lauak Group for manufacturing the pump parts and keep final assembly in House

Preliminary meetings underway with the FDA to outline pre-clinical trial details and initiate the process to obtain designation of Breakthrough Technology

Numerous preclinical trials have succeeded with promising results

Research centers where the First In Human implantations will be carried out have been selected.