FDA Gives Breakthrough Device Designation for Puzzle Medical Devices Inc.’s Transcatheter Heart Pump

The U.S. Food and Drug Administration (FDA) has granted Puzzle Medical Devices Inc. a Breakthrough Device Designation for its minimally invasive transcatheter heart pump. The revolutionary device is meant for patients with minimal trauma for blood components to support heart function efficiently and safely without need for open-heart surgery. In light of the FDA Breakthrough Device Designation announcement, Jade Doucet-Martineau, co-founder and CEO of Puzzle Medical, stated, “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.”

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