Supira Medical Receives FDA Approval for SUPPORT II Trial and Strengthens Its Clinical Strategy

Supira Medical's FDA Breakthrough

Supira Medical, Inc., a clinical-stage company focusing on revolutionizing the market for percutaneous ventricular assist devices (pVADs), has recently announced a major advancement in its clinical journey. On April 8, 2026, the company received FDA approval to commence the SUPPORT II pivotal study, which aims to support a future Premarket Approval (PMA) application. This milestone is crucial for the future commercial introduction of their technology in the United States.

The SUPPORT II study will investigate the safety and efficacy of the next-generation pVAD in patients undergoing high-risk percutaneous coronary interventions (HRPCI). This prospective, randomized, controlled trial is expected to enroll up to 385 patients across 40 sites in the U.S. The study is led by notable experts, including Dr. Ajay Kirtane from Columbia University and Dr. David Kandzari from Piedmont Heart Institute.

Advancements in Cardiogenic Shock Treatment

In addition to the SUPPORT II study, Supira Medical is actively pursuing opportunities to improve treatment options for patients experiencing cardiogenic shock. Recent experiences outside the U.S. have demonstrated the use of a percutaneous axillary approach, enhancing mobility for patients requiring active mechanical support with a 10Fr pVAD.

These advancements reflect the potential for the next generation of temporary mechanical circulatory support systems to enhance accessibility, support patient mobility, and improve overall medical interventions for critically ill patients. Providing full hemodynamic support while allowing for flexibility in percutaneous access signifies a pivotal evolution in treating patients with cardiogenic shock.

Dr. Kirtane emphasized the significance of a well-deployed pVAD allowing physicians to safely conduct highly complex procedures with patients who had limited options available during HRPCI. The initiation of this critical randomized study with a novel, less invasive device marks an important step forward in advancing care for at-risk patients.

Appointment of D. Keith Grossman to the Board

Alongside this clinical progress, Supira Medical has announced the appointment of D. Keith Grossman as an independent board member. With 40 years of experience in the medical device sector, including a key role in mechanical circulatory support, Grossman’s expertise will strengthen the company's focus on scaling its operations towards market readiness and growth.

As stated by Dr. Nitin Salunke, the President and CEO of Supira Medical, Keith brings a valuable mix of operational discipline, commercial insight, and strategic perspective to the team. His inclusion signifies the company's commitment to develop not only clinically differentiated products but also mobilize the company for large-scale operations.