Supira’s SUPPORT II Pivotal Trial of pVAD System Approved by FDA

April 9, 2026—Supira Medical, Inc. announced FDA approval to initiate the SUPPORT II pivotal trial of the Supira percutaneous ventricular assist device (pVAD) system.

According to the company, SUPPORT II is a prospective, randomized controlled study designed to assess the safety and efficacy of its next-generation pVAD system in patients undergoing high-risk percutaneous coronary intervention (HRPCI).

The trial, which is intended to support a future premarket approval submission, will enroll up to 385 patients at up to 40 United States sites, noted the company.

SUPPORT II is led by National Coprincipal Investigators Ajay Kirtane, MD, and David Kandzari, MD.

“In HRPCI, the decision to use hemodynamic support is often influenced by access, deliverability, and the balance between support and procedural efficiency,” commented Dr. Kandzari in Supira’s press release. “A system that can provide effective circulatory support with a smaller profile has the potential to expand the available treatment population and improve effectiveness.”

Dr. Kirtane added, “The appropriate use of a pVAD allows physicians to safely perform procedures of the highest complexity, offering HRPCI to patients who previously had limited options. The initiation of this pivotal randomized trial of a novel, lower-profile hemodynamic support device is an important step in advancing the care of some of our highest risk patients.”

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

Separately from SUPPORT II, the company is investigating treatment options for patients experiencing cardiogenic shock. It reported that an initial series of cardiogenic shock patients outside the United States were treated using percutaneous axillary access to enable patient ambulation with an active 10-F pVAD device.

Additionally, Supira announced the appointment of D. Keith Grossman to its Board of Directors. Mr. Grossman’s 40-year leadership experience in the medical technology industry includes a foundational role in the mechanical circulatory support space, stated the company.