Puzzle Medical has announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its 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 prioritised 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, 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.”
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 Alain Cribier, of Rouen, France.
“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.”