FDA breakthrough device designation given to MI transcatheter heart pump

Puzzle Medical Devices Inc.’s transcatheter heart pump is one step closer to commercialization.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the firm’s ModulHeart, a transcatheter pump designed to address heart failure. The pump is designed to help patients avoid open-heart surgery and reduce blood trauma, which consequently will help minimize periprocedural and long-term complications.

“The FDA’s recognition of Puzzle Medical’s heart pump as a Breakthrough Device is a testimony to the innovative and disruptive nature of this device,” said Philippe Généreux, M.D., interventional cardiologist at Gagnon Cardiovascular Institute, Morristown Medical Center, New Jersey, and chief medical officer of Puzzle Medical. “This technology has the potential to help millions of patients suffering from heart failure who currently have no treatment option other than medical therapy.”

The FDA’s Breakthrough Device Program is intended to help patients receive more timely access to certain medical devices that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions, including a prioritized review of market approval regulatory submissions.

Puzzle Medical’s focus is to improve patient quality of life and reduce the global economic burden related to heart failure. Puzzle Medical is developing a proprietary transcatheter heart pump associated with minimal trauma to the blood components, allowing for safe and efficient heart support without open-heart surgery.

“I have been impressed by the progress made by the Puzzle Medical team so far. Their device clearly answers an unmet need among patients suffering from heart failure,” said Professor Alain Cribier, M.D., of Rouen, France.

The ModulHeart’s pump components, made of biocompatible materials, are introduced one at a time by catheter into the femoral artery. Once in the descending thoracic aorta, a docking device allows the pump propellers to be assembled and aligned in parallel.
The product’s propellers speed up the blood flow out of the left ventricle so as to propel the blood through the rest of the body. A battery-powered electric controller synchronizes the propeller motor with the heartbeat to prevent the pump from drawing blood from the brain.

“Puzzle Medical is excited about this important milestone and is thankful to the FDA for the Breakthrough Device Designation,” said Jade Doucet-Martineau, co-founder and CEO of Puzzle Medical. “Leveraging decades of expertise in the development of transcatheter therapies, the Puzzle Medical team will fiercely continue the development of the most efficient and safest heart pump ever created.”

MPO