Supira Medical announced today that it initiated the first-in-human clinical study of its percutaneous ventricular assist device (pVAD).
Los Gatos, California-based Supira, a Shifamed portfolio company, is using the pVAD in a prospective, single-arm, single-center study. It will evaluate the safety and performance of the low-profile, high-flow pVAD to support cardiovascular hemodynamics in patients undergoing high-risk percutaneous coronary interventions (HRPCI).
pVADs are used during stent placement or angioplasty to provide mechanical support for high-risk patients with severe coronary artery disease or comorbidities. pVADs can be used to treat patients suffering from cardiogenic shock as well.
Dr. Adrian Ebner, head of the cardiovascular department at the Italian Hospital Asuncion Paraguay, initiated the study. Ebner is principal investigator for the study. Dr. Gagan Singh (University of California, Davis), Dr. Susheel Kodali (New York Presbyterian/Co…