Supira Medical Announces FDA Approval for SUPPORT II Pivotal Trial

Advances in Cardiogenic Shock and Appointment of D. Keith Grossman to Board of Directors

Apr. 8, 2026 at 12:19pm

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Supira Medical, a clinical-stage company focused on transforming the percutaneous ventricular assist device (pVAD) market, announced FDA approval to initiate the SUPPORT II Pivotal Trial, a critical step toward U.S. market entry. The company also shared advances in treating cardiogenic shock and the appointment of medical device industry veteran D. Keith Grossman to its Board of Directors.

Why it matters

The SUPPORT II trial is designed to assess the safety and efficacy of Supira's next-generation pVAD in patients undergoing high-risk percutaneous coronary intervention (HRPCI), which can be a complex and risky procedure. Advances in treating cardiogenic shock, a high-mortality condition, and the addition of an experienced industry leader to the board signal Supira's progress in developing innovative solutions to support cardiovascular function.

The details

The SUPPORT II trial will enroll up to 385 patients at up to 40 U.S. sites and is led by national co-principal investigators Dr. Ajay Kirtane and Dr. David Kandzari. Separately, Supira has been pursuing opportunities to improve treatment options for patients experiencing cardiogenic shock, including the use of percutaneous axillary access to enable patient ambulation with an active 10Fr pVAD. Additionally, the company announced the appointment of D. Keith Grossman, a 40-year medical technology industry veteran, to its Board of Directors.

  • Supira Medical announced FDA approval to initiate the SUPPORT II Pivotal Trial on April 8, 2026.
  • The company has been pursuing opportunities to improve treatment options for patients experiencing cardiogenic shock.

The players

Supira Medical, Inc.

A clinical-stage company focused on transforming the percutaneous ventricular assist device (pVAD) market.

Dr. Ajay Kirtane

Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons/New York-Presbyterian Hospital and national co-principal investigator for the SUPPORT II trial.

Dr. David Kandzari

Chief of the Piedmont Heart Institute and Chief Scientific Officer for Piedmont Healthcare, Atlanta, GA, and national co-principal investigator for the SUPPORT II trial.

D. Keith Grossman

A 40-year medical technology industry veteran who has been appointed to Supira Medical's Board of Directors.

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What they’re saying

“In HRPCI, the decision to use hemodynamic support is often influenced by access, deliverability, and the balance between support and procedural efficiency. 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. David Kandzari, Chief of the Piedmont Heart Institute and Chief Scientific Officer for Piedmont Healthcare, Atlanta, GA

“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.”

— Dr. Ajay Kirtane, Professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons/New York-Presbyterian Hospital

“Supira has established a compelling clinical and technological foundation that is uniquely positioned to change the growing and still under-penetrated pVAD landscape. I look forward to supporting the company as it advances its pivotal trial and prepares to become a leading presence among treatment options for high-risk PCI and cardiogenic shock patients.”

— D. Keith Grossman

What’s next

The SUPPORT II Pivotal Trial is expected to enroll up to 385 patients at up to 40 U.S. sites, with Dr. Kirtane and Dr. Kandzari serving as national co-principal investigators.

The takeaway

Supira Medical's progress in developing its next-generation pVAD, including FDA approval for the SUPPORT II trial and advances in treating cardiogenic shock, demonstrates the company's commitment to transforming the pVAD market and improving outcomes for high-risk cardiac patients. The addition of industry veteran D. Keith Grossman to the board further strengthens Supira's commercial and operational capabilities as it prepares for potential market entry.