Surmodics announces results from PROWL registry study

The company states: “Surmodics (SRDX) announced that results from a sex-specific analysis of 160 real-world acute, subacute, and chronic thrombotic limb ischemia patients from its PROWL registry study were presented by Dr. Peter Monteleone at the 37th Annual TCT Symposium in San Francisco, CA. PROWL is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce(TM) Thrombectomy Platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The registry is collecting real-world efficacy and safety outcomes data for endovascular interventions using the fully mechanical, non-aspiration-based Pounce Thrombectomy Platform for up to 500 patients at up to 30 sites. The core lab-adjudicated study is enrolling all patients treated with the Pounce Platform, including those with shortened life expectancy, history of cancer or COVID-19, prior interventions to the target limb, and symptom duration up to and beyond 28 days. The full results of the PROWL registry will be presented on November 3, 2025, at the VIVA Vascular Symposium. On October 28, 2025, study investigator Dr. Monteleone, on behalf of the PROWL investigators and National Co-Principal Investigators Dr. Sean Lyden, Chairman of the Department of Vascular Surgery, Cleveland Clinic, and Dr. Joseph Campbell, Interventional Cardiologist, OhioHealth, presented results from a sex-specific analysis of the 160-patient infrainguinal PROWL subset. Most patients in this subset were treated with the Pounce Thrombectomy System, indicated for use in peripheral arteries 3.5-6 mm in diameter. The analysis examined a subset of 160 patients (60 female, 100 male) who received Pounce Platform treatment in symptomatic, infrainguinal vessels, followed through 30 days. Procedural success, defined as restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment (patient level success), was achieved in 94.7% of female and 89.9% of male patients (p=0.3765). Technical success, defined as restoration of blood flow to the target lesion(s) with less than50% residual obstruction without the need to initiate catheter-directed thrombolysis or to proceed to open surgery or other endovascular thrombectomy devices (lesion-level success), was achieved in 91.4% and 78.3% of target lesions for female and male patients, respectively, and reflected a significant difference between groups (p=0.0261). Core lab adjudicated thrombus removal was complete or substantial in 93.8% of female patients and 94.3% of male patients, including 71.4% of female patients and 78.9% of male patients following use of the Pounce Thrombectomy Platform. These differences were not statistically significant between groups. Arterial flow improved in 97.2% of female patients and 93.4% of male patients (TIPI Grade 2/3). The composite outcome of freedom from all-cause major adverse events (MAEs), comprising mortality, major amputation, and clinically driven target lesion revascularization, was seen in 73.3% of female patients and 86.0% of male patients (p=0.0599).”