Supira Medical Gains FDA Nod for SUPPORT II Trial and Welcomes New Board Member

Supira Medical, Inc., a clinical-stage company centered on advancing the percutaneous ventricular assist device (pVAD) market, has received FDA approval to commence the SUPPORT II Pivotal Trial. This trial is a key step towards a future PMA submission and U.S. market entry. The SUPPORT II trial will evaluate the safety and efficacy of Supira's next-gen pVAD in high-risk percutaneous coronary intervention (HRPCI) patients. Enrolling up to 385 patients at 40 sites, it is led by key investigators Drs. Kirtane and Kandzari.

Additionally, Supira is innovating treatments for cardiogenic shock, enhancing patient mobility with a 10Fr pVAD. These initiatives mark significant strides in mechanical circulatory support, improving access and patient outcomes. Concurrently, Supira has appointed D. Keith Grossman to its Board of Directors, reinforcing its strategic and growth-focused approach in the medical technology industry.