Supira Medical announced today that it began patient enrollment in a U.S. early feasibility trial of its percutaneous ventricular assist device (pVAD).
The Shifamed portfolio company plans to evaluate the pVAD in patients undergoing high-risk percutaneous coronary intervention (HRPCI). Los Gatos, California-based Supira’s study looks at the safety and feasibility of the low-profile, high-flow device.
The pVAD technology involves a high-flow from a low-profile catheter pump with real-time monitoring. The goal is to minimize vascular complications.
Dr. David Kandzari, chief of the Piedmont Heart Institute and national principal investigator, performed the first case.
“I am pleased to share that Supira’s U.S. EFS began with its first successful enrollment, supporting the enthusiasm among investigators to bring this program to the U.S.,” Kandzari said. “The Supira pump delivers impressive flow rates through a remarkably small profile, with a console that supports simplified workflows. This unique combination promises to address limitations of presently available options while enhancing cath lab efficiency.”
pVADs support cardiovascular function during HRPCI. They’re particularly important in patients with complex coronary anatomy, compromised hemodynamics, and multiple comorbidities. Additional uses include in cardiogenic shock, a high-mortality condition.
Supira announced the first human use of its pVAD just over two years ago.
“We believe the Supira System is a transformative innovation and look forward to expanding the significant body of evidence from our 70-patient South America experience. With these U.S. cases, we are one step closer to our goal of reshaping outcomes for patients while delivering value for physicians and the healthcare system,” commented Dr. Nitin Salunke, President and CEO of Supira. “I would like to thank our clinical advisors for their strong, continued support and our team for their tireless efforts to achieve this historic milestone.”
