Puzzle Medical Devices Inc. is incredibly proud to have been peer reviewed & published by the Journal of the Society for Cardiovascular Angiography & Interventions for its First-in-Human Experience with the ModulHeart Device for Mechanical Circulatory Support and Renal Perfusion.
Congratulations to the entire team.
Gabriel Georges, MD, Francois Trudeau, Jade Doucet-Martineau, B. Eng., Maxime Rochon, Jeannot Potvin, MD, Adrian Ebner, MD, Philippe Généreux
-
Results
On June 28 and 29, 2022, 4 patients were enrolled and underwent high-risk PCI with ModulHeart implanted via transfemoral approach. All 4 patients achieved procedural success. The mean pressure gradient across the pump was 5 ± 2 mm Hg. Under ModulHeart support, cardiac index increased by 25%, central venous pressure decreased by 37%, and left ventricular end-diastolic pressure decreased by 78%. Urine output increased by ∼9-fold after 15 minutes of support. No device malfunction or procedural or device-related adverse events occurred. There was no evidence of pump thrombosis. All 4 patients were alive at 30 days.