Surmodics has enrolled the first patient in the PROWL registry, a retrospective study focused on evaluating the effectiveness of the Pounce Thrombectomy System.
The multi-centre, open-label registry is evaluating the use of the Pounce system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.
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The US registry is intended to collect data on the safety and efficacy outcomes of endovascular interventions that deploy the Pounce system, from 500 patients across up to 30 sites in real-world settings.
Cleveland Clinic vascular surgery department chairman Sean Lyden and OhioHealth interventional cardiologist Joseph Campbell are serving as national co-principal investigators for the study.
Procedural success is the primary efficacy endpoint of the trial, while the incidence of device-related major adverse events through 30 days is the primary safety endpoint.
Surmodics president and CEO Gary Maharaj said: “With hospitals increasingly short on staff and beds, physicians need a simple and effective tool that lets them restore arterial flow right on the table without resorting to time-consuming and costly adjunctive treatments.
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By GlobalData“We are confident the PROWL registry will demonstrate these exceptional attributes of the Pounce system in real-world clinical practice.”
The Pounce Thrombectomy System consists of a 5Fr delivery catheter, a funnel catheter and a basket wire.
The basket delivery catheter delivers the basket wire assembly distal to the location of the thrombus. Two nitinol self-expanding baskets are then deployed to capture the clot, following which they will be retracted into the nitinol collection funnel.
The system is withdrawn into a minimum 7Fr guide sheath and the clot is expelled from the body.
