Puzzle Medical Devices Inc., (www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address 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.
“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, MD, interventional cardiologist at Gagnon Cardiovascular Institute, Morristown Medical Center, New Jersey, USA, and Chief Medical Officer of Puzzle Medical. “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.”