Surmodics Reports Early Clinical Use of Pounce XL Thrombectomy System

February 3, 2025—Surmodics, Inc. announced the early clinical use of its Pounce XL thrombectomy system, which is currently in limited market release.

According to the company, Pounce XL received FDA 510(k) clearance in September 2024. A full commercial launch is planned following completion of the limited market release.

Surmodics stated that its Pounce thrombectomy systems are intended for the nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature. The new Pounce XL is indicated for use in vessels ranging from 5.5 to 10 mm in diameter, which are sizes typical of iliac and femoral arteries. The Pounce XL complements the Pounce and Pounce LP thrombectomy systems, which are indicated for 3.5 to 6 mm and 2 to 4 mm vessels, respectively.

Walter Rizzoni, MD, who is a vascular surgeon at the University of Pittsburgh Medical Center’s UPMC Hamot Hospital in Erie, Pennsylvania, successfully used the new Pounce XL thrombectomy system to restore blood flow in a thrombosed stent graft 8 mm in diameter. The procedure was Dr. Rizzoni’s first case using the device.

“The Pounce XL thrombectomy system removed a significant amount of chronic material during our first use,” said Dr. Rizzoni. “In that respect, its performance was right in line with our experience using the Pounce and Pounce LP Systems.”

The company further announced that on January 29, 2025, early results from the PROWL registry were presented at LINC 2025, the Leipzig Interventional Course held January 28-30 in Leipzig, Germany. PROWL is an open-label, retrospective, multicenter, United States registry of the Surmodics Pounce thrombectomy platform for the nonsurgical removal of emboli and thrombi in the peripheral arterial vasculature.

According to Surmodics, a subset analysis of 74 PROWL patients with symptoms of limb ischemia demonstrated 97.1% TIPI (thrombo-aspiration in peripheral ischemia) 2 to 3 procedural flow restoration, with 79.7% of patients not receiving additional thromboemboli removal treatment after use of the Pounce or Pounce LP system

Additionally, four in 10 (40.5%) patients in the cohort presented with symptoms of subacute (15-28 days) or chronic (> 28 days) limb ischemia, which is a marked difference from previous studies of pharmacomechanical or aspiration peripheral arterial thrombectomy limited to ≤ 14-day limb ischemia, stated the company.