Puzzle Medical Devices’ ModulHeart Evaluated in FIH Study for Cardiorenal Support in High-Risk PCI

September 29, 2022—The Society for Cardiovascular Angiography and Interventions (SCAI) recently announced that a first-in-human (FIH) study demonstrated that use of the ModulHeart modular pump (Puzzle Medical Devices Inc.) resulted in significant improvement in cardiac output, left ventricular end-diastolic pressure (LVEDP), and urine output in patients with heart failure or undergoing high-risk percutaneous coronary intervention (PCI).

According to SCAI, the ModulHeart is implanted percutaneously to provide hemodynamic support through three endovascular pumps that are inserted in series and assembled in parallel into a dedicated self-expandable anchor in the descending aorta.

The study’s findings were presented at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts. The study was simultaneously published online by Gabriel Georges, MD, et al in the society’s journal, JSCAI.

Philippe Généreux, MD, an interventional cardiologist at the Gagnon Cardiovascular Institute at Morristown Medical Center in Morristown, New Jersey, is senior author of the study.

“The FIH experience using the ModulHeart device was extremely positive, showing great cardiorenal support and pump function,” commented Dr. Généreux in the SCAI press release.

Dr. Généreux added, “The device was easy to deliver and assemble. Once in place, it provided substantial hemodynamic benefits. I am looking forward to the upcoming studies to reduce congestion in patients with acute decompensated heart failure.”

As summarized in the SCAI press release, four patients were enrolled in the FIH study in June 2022 and underwent high-risk PCI with ModulHeart implanted via a transfemoral approach. Mean delivery time was 8 minutes, support time was 49 minutes, and pump removal time was 7 minutes.

The investigators reported that under ModulHeart support, cardiac index increased by 25%, central venous pressure decreased by 37%, and LVEDP decreased by 78%. Urine output increased by approximately ninefold after 15 minutes of support. There was no device malfunction or procedural or device-related adverse events. All patients were alive at 30 days postprocedure.

The current study was performed among patients undergoing high-risk PCI with some degree of LV dysfunction. Future studies will target patients with acute and chronic decompensated heart failure with more profound reduced ejection fraction and requiring hemodynamic support and will also explore longer use of the device during the procedure, advised the investigators in the SCAI press release.