Supira Medical FDA Trial Approval

Supira Medical, a clinical-stage company, announced that the United States — Food and Drug Administration has approved the initiation of its SUPPORT II Pivotal Trial. This trial is a prospective, randomized controlled study designed to assess the safety and efficacy of Supira Medical's next-generation percutaneous ventricular assist device (pVAD) in patients undergoing high-risk percutaneous coronary intervention (HRPCI). The study will enroll up to 385 patients across 40 U.S. sites and is co-led by Ajay Kirtane and David Kandzari. In parallel, Supira Medical also announced the appointment of medical device industry veteran D. Keith Grossman to its Board of Directors, aiming to strengthen its commercial foundation and scale towards market readiness. The company is also pursuing opportunities to improve treatment options for patients experiencing cardiogenic shock, with recent case experience outside the U.S. demonstrating the use of percutaneous axillary access for patient ambulation with an active 10Fr pVAD.