#USA #FDA Approval #Los Gatos #Supira Medical #SUPPORT II

Supira Medical's Key Announcements

Supira Medical, Inc., an emerging leader in clinical-stage medical research, has recently made headlines with significant advancements in the treatment of cardiac shock and the announcement of FDA approval for its pivotal SUPPORT II study. This milestone not only represents a critical step in offering innovative solutions for patients undergoing high-risk interventions but also underscores Supira's commitment to enhancing cardiovascular care.

FDA Approval for SUPPORT II Study

On April 9, 2026, Supira Medical announced that it had received approval from the FDA for initiating its SUPPORT II study. This study aims to evaluate the safety and effectiveness of the company's next-generation percutaneous ventricular assist devices (pVAD) in patients who have undergone high-risk percutaneous coronary interventions (PCI). The SUPPORT II trial is a prospective, randomized controlled study that will enroll up to 385 patients across 40 research centers in the United States and will be co-led by esteemed cardiologists Dr. Ajay Kirtane from Columbia University and Dr. David Kandzari from Piedmont Heart Institute.

Dr. Kirtane expressed the importance of advancing hemodynamic support options, stating, "The right pVAD can safely facilitate the most complex procedures, significantly benefiting patients who previously had limited options."

This pivotal research aims to generate the necessary data that will support a future premarket approval (PMA) application, thereby taking a vital step towards market entry in the U.S. healthcare landscape. The ability to provide effective circulatory support with a lower profile can potentially broaden the patient population eligible for such treatments while simultaneously enhancing procedural efficacy.

Trailblazing Innovations in Cardiogenic Shock Treatment

In parallel to the SUPPORT II study, Supira Medical is actively exploring improved treatment alternatives for patients experiencing cardiogenic shock. The company has recently conducted a pilot series evaluating the use of pVAD through a percutaneous axillary access, facilitating greater patient mobility without compromising treatment effectiveness.

Such innovations highlight the potential for next-generation temporary mechanical circulatory support options to improve patient outcomes significantly. These breakthroughs in hemodynamic support—along with increased access and enhanced mobility for critically ill patients—represent crucial advancements in the management of cardiovascular emergencies.

Leadership Change: Welcome D. Keith Grossman

Alongside these clinical milestones, Supira Medical has announced the appointment of D. Keith Grossman to its board of directors. With over 40 years of experience in the medical device industry—especially in mechanical circulatory support—his expertise is expected to bolster the company's strategy to scale its readiness for market growth.

Company President and CEO Nitin Salunke noted, "Keith brings a valuable combination of operational discipline, commercial insights, and strategic vision. His role on our board represents our commitment to developing an organization that is not only clinically differentiated but also capable of executing at scale."

Grossman expressed his enthusiasm, stating, "Supira has established a compelling clinical and technological foundation, possessing unique capabilities to transform the evolving landscape of pVADs. I look forward to supporting the company as it advances its key research and positions itself as a leader in treating high-risk patients with PCI and cardiogenic shock."

About Supira Medical, Inc.

Supira Medical focuses on developing the next generation of pVADs for use in high-risk patients undergoing interventional procedures and experiencing cardiogenic shock. To date, the Supira device has been utilized in 99 patients. As their efforts to revolutionize cardiovascular care continue, Supira is paving the way for future advancements in patient management during highly complex procedures. For more information on Supira Medical, visit supiramedical.com.

Note: The Supira system is investigational and not approved for sale in the U.S. or elsewhere. Federal law restricts the use of this device to investigational purposes only.