A New and Effective Ventricular Assist Device for High-Risk PCI

The results of a first-in-human (FIH) trial demonstrated that Supira Medical’s novel, low profile and high flow Supira 10F system is a safe and effective percutaneous ventricular assist device (pVAD) for the completion of high-risk percutaneous coronary interventions (PCI). The findings were presented today at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions.

Current FDA approved pVAD devices have large profiles that are linked with high rates of vascular complications. At maximum flow rates, these devices are rife with cases of hemolysis. The novel Supira 10F system was developed to rectify previous design limitations. And how does it work? “The device is an expandable axial flow 21 Fr pump in its nominal state and is sheathed to 10Fr for delivery and removal. In its nominal state, the device provides continuous unloading throughout the cardiac cycle. The system is delivered via rapid exchange (“RX”) over a pre-established LV rail wire. Once positioned trans-valvular, the guidewire is removed and the axial pump is initiated,” the investigators said.

In this FIH, single-arm, single-center study, conducted by Gagan Singh, MD, and colleagues, six patients underwent high risk PCI using the Supira 10F. The primary outcomes were stipulated as a composite endpoint of procedural and safety success. The researchers noted that procedural success was
defined as: safe implantation of device, hemodynamic support during the PCI, and successful withdrawal of the device. They defined safety success as: freedom from device-related major adverse events (MAEs), such as vascular complications, aortic valve injury, mitral valve injury, and systemic embolization.

A “Meaningful Advancement”

The results showed that the device met the composite endpoint, achieving 100% procedural success, with no device related AEs reported, and no early indicators of clinically significant hemolysis. “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,” said Dr. Singh, Director of Clinical Cardiovascular Research at University of California, Davis, presenting author and study lead, via a press release about the trial.

Dr. Singh added that: “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.”

Source: Singh G, Kodali S, Ebner A. First-in-human experience with a novel (low profile, high flow) percutaneous ventricular assist device. Abstract 24776. Published for the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions; May 18-20, 2023, Phoenix, AZ.