Compliance / Regulatory

Montreal, QC, Canada

Puzzle Medical is developing the ModulHeart, a modular percutaneous heart pump designed to reduce cardiac afterload and improve renal perfusion in patients with advanced heart failure who are not candidates for heart transplant or surgical mechanical circulatory support. The device’s modular design allows for hemodynamic support through multiple pumps anchored in parallel in the descending aorta. The design is expected to increase accessibility by enabling safe percutaneous implantation to support both renal and cardiac function, with low risk of bleeding, stroke, and pump thrombosis, while providing sustained symptom relief, reduced re-hospitalizations, and improved overall quality of life. To date, Puzzle Medical has successfully completed its first-in-human study with all patients experiencing improvements in cardiac and kidney function (2022); completed a Seed financing round (2021); built a strong Key Opinion Leaders committee (2021); received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation (2021).

Montréal, QC, Canada

Puzzle Medical Devices

Spontaneous application (Clinical & Regulatory)

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Spontaneous application (Clinical & Regulatory)