PROWL Evaluates Surmodics’s Pounce Thrombectomy Platform in Treatment of Limb Ischemia

November 11, 2025—Surmodics, Inc. announced new real-world results from the PROWL registry evaluating the company’s Pounce thrombectomy platform for nonsurgical removal of emboli and thrombi in the peripheral arterial vasculature. The findings were presented at VIVA25 by National Coprincipal Investigators Sean Lyden, MD, and Joseph Campbell, MD, with study investigator Peter Monteleone, MD.

According to Surmodics, PROWL is an ongoing, open-label, multicenter registry designed to collect safety and efficacy outcomes in up to 500 patients at up to 30 sites in the United States.

The core lab–adjudicated registry includes all-comer patients, including those with extended symptom duration, previous limb interventions, or history of cancer or COVID-19; and 43.1% of patients had symptom duration > 2 weeks, noted the company.

As summarized in the Surmodics’ press release, the analysis that included 160 patients with symptomatic infrainguinal limb ischemia demonstrated the following:

• The primary effectiveness endpoint of procedural success was achieved in 91.7% of target lesions with or without adjunctive treatment
• The primary safety endpoint of device-related major adverse events (MAEs) through 30 days occurred in 0.6% (n = 1) of patients
• Core lab–adjudicated thrombus removal was complete or substantial in 94.1% of patients, with an average procedure time of 24.1 minutes and a median of two passes per patient
• Final postprocedural blood flow restoration to thrombolysis in peripheral ischemia (TIPI) 2–3 was achieved in 94.8% of cases.

The company reported that among this heterogeneous population, 78.8% of patients did not require additional thrombolysis or thrombectomy after use of the Pounce platform, and one patient experienced a device-related adverse event. There were no device-related distal embolizations or deaths.

Finally, 30-day all-cause MAEs included major amputation (8.1%), clinically driven target lesion revascularization (7.5%), and death (4.4%), reported Surmodics.