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. Can Supira’s pVAD support cardiovascular hemodynamics in patients undergoing high-risk percutaneous coronary interventions (HRPCI)?
Health practitioners use pVADs during stent placement or angioplasty. The catheter-delivered devices can provide mechanical support for high-risk patients with severe coronary artery disease or comorbidities. It’s possible to use pVADs o treat patients suffering from cardiogenic shock as well.
Abiomed and its Impella heart pump technology are a major force in the pVAD space. Abiomed announced today that the FDA has approved more research into using Impella pumps to treat cardiogenic shock, which can happen after severe heart attacks.
Supira enters the clinical stage
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/Columbia University Medical Center) and Dr. Azeem Latib (Montefiore Health Systems) were present to observe the first procedures, according to a news release.
“Today marks an important milestone as Supira transitions to a clinical-stage company,” said Dr. Nitin Salunke, president and CEO of Supira Medical. “I would like to thank Dr. Ebner and the entire clinical team for their seamless execution of these first cases. We are grateful to our clinical advisors, Drs. Singh, Kodali and Latib, for prioritizing this study and traveling to share this initial clinical experience.”
Singh said he is “pleased to be part” of the cases and remains impressed by the Supira pump’s performance. He said it can deliver high flow through a small profile, addressing the risks of vascular complications associated with current devices.
“Achieving high flow rates has typically required larger devices which can be challenging from both an access and positioning perspective,” said Dr. Kodali. “In my opinion, Supira’s technology was easily placed and performed well. This is a meaningful advancement that will allow more operators to confidently perform HRPCI procedures.”