Surmodics Commences PROWL Registry of Pounce Thrombectomy System

April 20, 2023—Surmodics, Inc. announced enrollment of the first patient in PROWL, an open-label, retrospective, multicenter, United States registry of the Surmodics Pounce system for the nonsurgical removal of emboli and thrombi in the peripheral arterial vasculature.

The registry will collect real-world efficacy and safety outcomes data for endovascular interventions using the Pounce system for up to 500 patients at up to 30 sites. PROWL’s primary efficacy endpoint is procedural success, and the primary safety endpoint is the incidence of device-related major adverse events through 30 days, stated Surmodics.

Sean Lyden, MD, and Joseph Campbell, MD, are National Coprincipal Investigators of the PROWL registry. Dr. Lyden is Chairman of the Department of Vascular Surgery at the Cleveland Clinic in Cleveland, Ohio. Dr. Campbell is an interventional cardiologist with OhioHealth in Columbus, Ohio.

The first site to enroll a patient in the registry was Baton Rouge General Medical Center in Baton Rouge, Louisiana.

“We are delighted to be the first site to enroll a patient in the PROWL registry,” commented Joseph Griffin, MD, in the Surmodics press release. Dr. Griffin, a vascular surgeon at Vascular Specialty Center, LLC, and Baton Rouge General Medical Center, continued, “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 intensive care unit stays. We’re eager to help track outcomes in this important study.”

Dr. Griffin added, “We have long needed better tools to help us resolve acute limb ischemia in a simple and effective manner, without the use of multiple adjunctive treatments. In this respect, our experience with the Pounce system has been quite positive.”

The Surmodics Pounce thrombectomy system includes three components: a 5-F delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7-F guide sheath through which the clot is removed from the body, stated the company.

Surmodics announced FDA 510(k) clearance for the Pounce system in September 2020.