Medical device and MedTech insights, news, tips and more

Puzzle Medical Receives FDA Breakthrough Device Designation for Transcatheter Heart Pump

February 14, 2021


Puzzle Medical Devices Inc., ( 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.”

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, MD, 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.”

About Puzzle Medical Devices Inc.

Puzzle Medical Devices Inc. ( is a Canadian company specializing in the development of a minimally invasive transcatheter heart pump. Puzzle Medical enables mechanical hemodynamic support to be more efficacious, safer, and more economical, resulting in increased accessibility, improved patient quality of life and reduction of the global economic burden related to the disease. To date, Puzzle Medical has successfully completed acute in-vivo preclinical implantations with tremendous success.

See Full Press Release at the Source: Puzzle Medical Receives U.S. Food and Drug Administration (FDA) Breakthrough Device Designation

Press Release by: Puzzle Medical

Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.

More insights

March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More
February 21, 2024
Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.