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Surmodics Announces Results from Sex-Specific Analysis of the PROWL Registry Study of Real-World Limb Ischemia Patients Treated with the Pounce™ Thrombectomy Platform

SRDX
  • Surmodics, Inc. presented sex-specific analysis results from its PROWL registry study at the 37th Annual TCT Symposium in San Francisco on October 28, 2025.
  • The analysis examined 160 patients (60 female, 100 male) with acute, subacute, or chronic thrombotic limb ischemia treated with the Pounce Thrombectomy Platform.
  • Procedural success was achieved in 94.7% of female patients compared to 89.9% of male patients, with no statistically significant difference between groups.
  • Technical success was significantly higher in female patients at 91.4% versus 78.3% in male patients (p=0.0261).
  • Core lab-adjudicated thrombus removal was complete or substantial in 93.8% of women and 94.3% of men, with no significant difference between sexes.
  • 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 major adverse events occurred in 73.3% of female patients and 86.0% of male patients, showing a trend toward less favorable outcomes for women (p=0.0599).
  • 41.7% of female patients and 44% of male patients presented with symptoms lasting longer than two weeks, reflecting heterogeneous real-world clinical presentations.
  • Nearly half of both women (48.5%) and men (47.3%) presented with Rutherford acute limb ischemia classification IIb or III, indicating immediately threatened limbs.
  • Dr. Peter Monteleone noted that while the Pounce Platform achieved high success rates, women experienced a trend toward less favorable clinical outcomes consistent with prior evidence of elevated risk for female patients.
  • Previous studies often excluded patients with symptom durations greater than 14 days, whereas this registry included patients with symptoms up to and beyond 28 days.
  • The PROWL registry is an open-label, retrospective, multi-center U.S. study collecting data on up to 500 patients across up to 30 sites.
  • Full results of the PROWL registry are scheduled to be presented at the VIVA Vascular Symposium on November 3, 2025.
  • The Pounce Thrombectomy Platform consists of FDA-cleared mechanical devices indicated for peripheral arteries ranging from 2 mm to 10 mm in diameter.
  • The system operates without the need for thrombolytics, aspiration, or capital equipment, utilizing a basket wire to capture \& remove clots.