Supira’s pVAD EFS for High-Risk PCI Begins Enrollment in United States

November 21, 2024—Supira Medical, Inc., a Shifamed portfolio company, announced the initiation of patient enrollment in the company’s United States early feasibility study (EFS) of its low-profile, high-flow percutaneous ventricular assist device (pVAD).

According to the company, the multicenter prospective, single-arm clinical study will evaluate the safety and feasibility of the Supira pVAD in patients undergoing high-risk percutaneous coronary intervention (PCI). The first procedure in the EFS was performed by national Principal Investigator David Kandzari, MD, who is Chief of the Piedmont Heart Institute in Atlanta, Georgia.

Results from the EFS will be used to support submission to the FDA for Supira’s pivotal investigational device exemption study, noted the company.

“I am pleased to share that Supira’s United States EFS began with its first successful enrollment, supporting the enthusiasm among investigators to bring this program to the United States,” commented Dr. Kandzari in the company’s press release. “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.”

The Supira system is an investigational device and is not approved for sale in the United States or anywhere in the world, advised the company.

In the press release, the company advised that the United States EFS expands its clinical program beyond the 70 patients already treated in its South America first-in-human (FIH) and feasibility studies.

In September 2022, Supira Medical announced the initiation of the FIH clinical study of the pVAD. The initial FIH procedures were performed by the study’s Principal Investigator, Adrian Ebner, MD, Head of the Cardiovascular Department at Italian Hospital Asuncion in Asuncion, Paraguay.

In May 2023, the initial results of the FIH trial, which demonstrated the safety and performance of the Supira pVAD system for cardiovascular hemodynamic support during high-risk PCI, were presented at the annual Society for Cardiovascular Angiography & Interventions scientific sessions.

In November 2023, the company announced that it received FDA Breakthrough Device designation for the Supira system.