Puzzle Medical Devices’ Transcatheter Heart Pump Receives FDA Breakthrough Device Designation

February 8, 2021—Puzzle Medical Devices Inc. announced that the FDA has granted a Breakthrough Device designation for the company’s revolutionary transcatheter pump to address heart failure.

Puzzle Medical, which is based in Montreal, Canada, stated that its transcatheter heart pump is associated with minimal trauma to the blood components, allowing for safe and efficient heart support without open heart surgery. To date, the company has successfully completed acute in vivo preclinical implantations.

Philippe Généreux, MD, an interventional cardiologist at Gagnon Cardiovascular Institute, Morristown Medical Center in Morristown, New Jersey, serves as Chief Medical Officer of Puzzle Medical. Dr. Généreux commented in the company’s press release, “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. This novel technology has the potential to help millions of patients suffering from heart failure who currently have no treatment option other than medical therapy.”

Professor Alain Cribier, MD, of Rouen, France, added, “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.”

The FDA 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, noted Puzzle Medical.