Surmodics Begins PROWL Registry Study for Pounce Thrombectomy

Surmodics has enrolled the first patient in PROWL, a retrospective registry for the Pounce thrombectomy system.
 
PROWL is an open-label, retrospective, multi-center, U.S. registry for Surmodics’ Punce system to non-surgically remove emboli and thrombi in peripheral arterial vasculature. The registry aims to gather real-world data for endovascular interventions using the system, for up to 500 patients at 30 sites.
 
The first site to enroll a patient in PROWL was Baton Rouge General Medical Center, Baton Rouge, La.
 
“We are delighted to be the first site to enroll a patient in the PROWL registry,” Dr. Joseph Griffin, Vascular Surgeon, Vascular Specialty Center, LLC and Baton Rouge General Medical Center, told the press. “In our experience, the Pounce system promptly removes peripheral arterial clot in a single treatment session while reducing the need for thrombolytic drugs and subsequent ICU stays. We’re eager to help track outcomes in this important study. We’ve long needed better tools to help us resolve acute limb ischemia in a simple and effective manner, without the use of multiple adjunctive treatments. In this respect, our experience with the Pounce system has been quite positive.”
 
Pounce is made up of three components: a 5 Fr delivery catheter, basket wire, and funnel catheter. The basket wire is delivered distal to the thrombus location and deploys two nitinol, self-expanding baskets. These baskets capture the clot and retract into the nitinol collection funnel. The system is then withdrawn into a minimum 7 Fr guide sheath, through which the clot is removed from the body.
 
The study’s primary endpoint is procedural success. The primary safety endpoint is incidence of device-related major adverse events through 30 days.
 
“Acute limb ischemia from arteries blocked by thrombus or embolus is an urgent threat to both limb and life,” said Gary Maharaj, president and CEO of Surmodics. “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. We are confident the PROWL registry will demonstrate these exceptional attributes of the Pounce system in real-world clinical practice.”