Surmodics Pounce Thrombectomy Platform Evaluated in Sex-Specific Analysis of PROWL Registry

November 6, 2025—Surmodics, Inc. announced results from a sex-specific analysis of its ongoing PROWL registry evaluating real-world use of the Pounce thrombectomy platform to treat thromboembolic limb ischemia.

The findings were presented by Peter Monteleone, MD, at the TCT scientific symposium. The full PROWL registry results were presented at the VIVA25 conference.

According to the company, the open-label, retrospective, multicenter United States PROWL registry is assessing outcomes of endovascular thrombus removal with the fully mechanical, nonaspiration Pounce platform in up to 500 patients across 30 sites. The National Coprincipal Investigators of PROWL are Sean Lyden, MD, and Joseph Campbell, MD.

The current analysis examined 160 patients (60 female, 100 male) with acute, subacute, or chronic thrombotic limb ischemia involving infrainguinal vessels and included 30-day follow-up.

Approximately half of all patients presented with high-acuity Rutherford class IIb or III disease and > 40% in both groups had symptom duration exceeding 2 weeks, noted Surmodics.

The company reported the following results in female and male patients, respectively:

• Procedural success—defined as restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment—was 94.7% and 89.9% (P = .3765).
• Technical success—defined as restoration of flow with < 50% residual obstruction without conversion to thrombolysis, open surgery, or other thrombectomy devices—was 91.4% and 78.3% (P = .0261).
• Complete or substantial core lab-adjudicated thrombus removal was achieved in 93.8% and 94.3% of patients.
• Arterial flow improvement (TIPI [thrombo-aspiration in peripheral ischemia] grade 2/3) was achieved in 97.2% and 93.4% of patients.
• Freedom from all-cause major adverse event—including mortality, major amputation, or clinically driven target lesion revascularization—was 73.3% and 86.0% (P = .0599).

“Use of the Pounce thrombectomy platform achieved high procedural success in both women and men, with significantly greater technical success in women,” commented Dr. Monteleone in Surmodics’ press release. “However, women experienced a trend toward less favorable clinical outcomes than men. These findings are consistent with prior evidence of elevated risk for female patients receiving limb ischemia interventions.”

Dr. Monteleone continued, “Acute limb ischemia is a hugely morbid and expensive disease, with enormous variability in patient presentation, clot characteristics, and the anatomic locations of these clots. This variability has made endovascular management of ALI very challenging using the thrombectomy tools previously available to us.”