Surmodics’ Pounce thrombectomy platform shows efficacy in limb ischemia study

Surmodics (SRDX) announced that results from an analysis of 160 real-world patients with symptomatic infrainguinal limb ischemia from its PROWL registry study were presented on November 3rd at the 23rd Annual VIVA Conference in Las Vegas. PROWL is an open-label U.S. registry of the Surmodics Pounce Thrombectomy Platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature. The analysis examined subjects with symptomatic infrainguinal vessels followed through 30 days. The primary effectiveness endpoint, procedural success in target lesion with or without adjunctive treatment, was 91.7%. The primary safety endpoint, incidence of device-related major adverse events from procedure to 30-day follow up, was 0.6%. The vast majority – 94.8% – of patients experienced final core lab adjudicated post-procedural TIPI 2-3 blood flow restoration. Device technical success, restoration of blood flow to the target lesion(s) with less than50% residual obstruction without the need of other therapies, was 83.2%. Core lab adjudicated procedural thrombus removal was complete or substantial in 94.1% of patients upon procedure completion. In this diverse PROWL cohort of acute, subacute, and chronic thrombotic presentations, 78.8% of patients did not require adjunctive treatments for clot removal following use of the Pounce Platform. Product use was well tolerated, with only 1 patient experiencing a device-related adverse event. There were no device-related deaths.