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Los Gatos Today
By the People, for the People
Supira Medical Receives FDA Approval for Cardiogenic Shock Trial
Pivotal SUPPORT II study will advance novel percutaneous ventricular assist device technology.
Apr. 8, 2026 at 1:22pm
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Supira Medical, a clinical-stage medical device company, has received FDA approval to initiate the SUPPORT II pivotal trial for its percutaneous ventricular assist device (pVAD) technology. The trial will evaluate the device's safety and efficacy in treating cardiogenic shock, a life-threatening condition where the heart is unable to pump enough blood to the body.
Why it matters
Cardiogenic shock is a major cause of in-hospital mortality, with limited treatment options currently available. Supira's pVAD technology aims to provide a less invasive alternative to traditional surgical ventricular assist devices, potentially improving outcomes for patients experiencing cardiogenic shock.
The details
The SUPPORT II trial will assess Supira's pVAD device, which is designed to be delivered percutaneously, or through a small incision, to provide temporary hemodynamic support. The company says the device's access, deliverability, and balance between support and procedural efficiency are key factors that will be evaluated in the study.
- The FDA approved Supira's application to initiate the SUPPORT II pivotal trial on April 8, 2026.
The players
Supira Medical, Inc.
A clinical-stage medical device company focused on transforming the percutaneous ventricular assist device (pVAD) market.
What’s next
Supira plans to enroll patients in the SUPPORT II trial at multiple clinical sites across the United States to evaluate the safety and efficacy of its pVAD technology in treating cardiogenic shock.
The takeaway
Supira's FDA-approved SUPPORT II trial represents an important step forward in developing less invasive treatment options for the serious and often fatal condition of cardiogenic shock. If successful, the company's pVAD technology could improve outcomes and access to life-saving hemodynamic support for patients experiencing this medical emergency.
