Early results from a first-in-human trial suggest Supira Medical’s next-generation percutaneous ventricular assist device (pVAD) is safe and effective for patients undergoing high-risk percutaneous coronary intervention (PCI) procedures.
The data, based on the first six patients who underwent high-risk PCI with the new device, were presented Friday, May 19, at the Society for Cardiovascular Angiography and Interventions (SCAI) 2023 Scientific Sessions.
The low-profile, high-continuous flow device from California-based Supira Medical was designed to limit hemolysis and other complications among patients undergoing high-risk PCI or in cardiogenic shock. Tracking its performance in these initial six patients, researchers noted that the procedural success rate was 100%. Also, no patients experienced device-related adverse events or displayed early warnings signs of significant hemolysis. The cohort’s average age was 58 years old, and five of the six patients were men. While four patients presented with a history of prior myocardial infarction, three presented with a history of diabetes. The support time for these patients ranged from 42 to 96 minutes.
“Initial safety results of the Supira’s pump performance are promising and point to a meaningful advancement, which could allow more operators to confidently perform high-risk PCI procedures while avoiding vascular complications,” lead author Gagan Singh MD, MS, director of the clinical cardiovascular research unit at the University of California, Davis, said in a statement. “This system features a unique combination of low profile and high continuous flow that offers the potential to minimize vascular complications and hemolysis while aiming to provide operators with a single device for multiple pVAD indications.”
Supira Medical’s pVAD device is still under development as the company tracks these first six patients. Multiple trials are currently being planned, including an early feasibility study in the United States scheduled to begin in late 2023.
Additional information about SCAI 2023 Scientific Sessions in Phoenix is available here. Click here to read about Supira Medical’s new medical director, interventional cardiologist Azeem Latib, MD.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.