Surmodics has announced that results from a sex-specific analysis of 160 real-world acute, subacute, and chronic thrombotic limb ischaemia patients from its PROWL registry study were presented by Peter Monteleone (Dell Medical School at the University of Texas at Austin, Austin, USA) at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference (25–28 October, San Francisco, USA).
PROWL is an open-label, retrospective, multicentre US registry of the Pounce 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 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 3 November 2025 at Vascular InterVentional Advances (VIVA; 2–5 November, Las Vegas, USA).
At TCT 2025, study investigator Monteleone, on behalf of the PROWL investigators and national co-principal investigators Sean Lyden (Cleveland Clinic, Cleveland, USA) and Joseph Campbell (OhioHealth, Columbus, USA), 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 3.5-6mm 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 <50% 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 revascularisation, was seen in 73.3% of female patients and 86% of male patients (p=0.0599).
Most previous studies of aspiration thrombectomy for symptomatic acute limb ischaemia (ALI) excluded patients with symptom duration greater than 14 days, and did not report on the presence of subacute or prolonged limb ischaemia among these patients. In this 160-patient PROWL registry subset, 41.7% of female patients and 44% of male patients presented with >2 weeks of symptoms, which Surmodics notes is a reflection of the heterogeneous clinical presentations seen in real-world treatment of peripheral ischaemia.
There was a high level of acuity among both women and men in the cohort. Nearly half (48.5%) of women, and 47.3% of men, presented with Rutherford ALI classification IIb or III, indicating immediately threatened limbs.
“Use of the Pounce thrombectomy platform achieved high procedural success in both women and men, with significantly greater technical success in women,” said Monteleone. “However, women experienced a trend toward less favourable clinical outcomes than men. These findings are consistent with prior evidence of elevated risk for female patients receiving limb ischemia interventions.”
In a 2020 analysis of 58,165 patients from the National Inpatient Sample, Hassan et al identified female sex as an independent predictor of major adverse events in acute or symptomatic chronic limb ischaemia requiring peripheral intervention (adjusted odds ratio, 1.36; 95% CI, 1.12–1.65; p=0.002).
Monteleone added: “Acute limb ischaemia 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. The Pounce thrombectomy platform is revolutionary—it gives physicians a reliable endovascular-first option for treating complex thromboembolic clots in high-risk patients without surgical embolectomy.”
