Surmodics recently announced it enrolled the first patient in its Prowl registry study of its Pounce thrombectomy system.
Prowl is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The registry aims to collect real-world efficacy and safety outcomes data for endovascular interventions. It will enroll up to 500 patients at up to 30 sites.
The first site to enroll a patient in the registry study was Baton Rouge General Medical Center in Baton Rouge, Louisiana. Dr. Sean Lyden, chairperson of the department of vascular surgery at the Cleveland Clinic, and Dr. Joseph Campbell, interventional cardiologist at OhioHealth, are national co-principal investigators.
“We are delighted to be the first site to enroll a patient in the Prowl registry,” Dr. Joseph Griffin, a vascular surgeon at the Vascular Specialty Center and Baton Rouge General Medical Center, said in a news release. “In our experience, the Pounce system promptly removes peripheral arterial clot in a single treatment session while reducing the need for thrombolytic drugs and subsequent ICU stays. We’re eager to help track outcomes in this important study.”
Prowl’s primary efficacy endpoint is a procedural success, while the primary safety endpoint is the incidence of device-related major adverse events through 30 days.
“Acute limb ischemia from arteries blocked by thrombus or embolus is an urgent threat to both limb and life,” Gary Maharaj, Surmodics president and CEO, said in a news release. “With hospitals increasingly short on staff and beds, physicians need a simple and effective tool that lets them restore arterial flow right on the table without resorting to time-consuming and costly adjunctive treatments. We are confident the PROWL registry will demonstrate these exceptional attributes of the Pounce system in real-world clinical practice.”
The Pounce thrombectomy system has three components: a 5 Fr delivery catheter, a basket wire and a funnel catheter. The basket wire is delivered distal to the location of the thrombectomy and deploys two nitinol self-expanding baskets. The basket then captures the clot and is retracted into the nitinol collection funnel. The system is withdrawn into a minimum 7 Fr guide sheath, through which the clot is also removed.
“We’ve long needed better tools to help us resolve acute limb ischemia in a simple and effective manner, without the use of multiple adjunctive treatments,” Griffin said. “In this respect, our experience with the Pounce system has been quite positive.”