Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced the successful early clinical use of its Pounce™ XL Thrombectomy System. The Pounce XL Thrombectomy System received U.S. Food and Drug Administration (FDA) 510(k) clearance in September 2024, and is currently in limited market release (LMR), with full commercial launch planned following completion of the LMR.
Surmodics Pounce Thrombectomy systems are intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. The new Pounce XL Thrombectomy System is indicated for use in vessels ranging from 5.5–10 mm in diameter, sizes typical of iliac and femoral arteries. The Pounce XL System complements the Pounce and Pounce LP Thrombectomy Systems, which are indicated for 3.5–6 mm and 2–4 mm vessels, respectively.
University of Pittsburg Medical Center (UPMC) Hamot vascular surgeon Dr. Walter Rizzoni successfully used the new Pounce XL Thrombectomy System to restore blood flow in a thrombosed stent graft 8 mm in diameter. This marks Dr. Rizzoni’s first case using the innovative device at the Erie, Pa. hospital.
“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.”
“We’re excited about the positive feedback we’ve received from early users of the Pounce XL System,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “The addition of this larger-profile device to the Pounce Thrombectomy Platform fulfills our goal of providing physicians a standalone solution for rapid removal of acute or chronic peripheral arterial clot throughout the lower extremity. With hospitals under growing pressure to reduce costs, we believe the standalone Pounce Thrombectomy Platform may help reduce the need for hospitalizations and follow-up procedures.”
About the Pounce Thrombectomy Platform
The Pounce Thrombectomy Platform comprises the Pounce Thrombectomy System, Pounce LP (Low-Profile) Thrombectomy System, and the Pounce XL Thrombectomy System. All are FDA-cleared, fully mechanical thrombectomy devices designed to promptly remove organized thrombus or embolus without the need for thrombolytics, aspiration, or capital equipment. They are indicated for use in peripheral arteries 3.5–6 mm, 2–4 mm, and 5.5–10 mm in diameter, respectively. The Pounce XL Thrombectomy System is currently pending full commercial release.
Described as “grab-and-go” solutions, Pounce Thrombectomy Platform systems are readily deployable and simple to use. Each system is composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered via the delivery catheter distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body.
About the PROWL registry
PROWL is an open-label, retrospective, multi-center, U.S. registry of the Surmodics Pounce™ Thrombectomy Platform for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.
On January 29, 2025, early results from the PROWL registry were presented at the 20th annual Leipzig Interventional Course (LINC) in Leipzig, Germany. Subset analysis of 74 PROWL patients with symptoms of limb ischemia demonstrated 97.1% TIPI 2-3 procedural flow restoration, with 79.7% of subjects not receiving additional thromboemboli removal treatment post Pounce or Pounce LP System use.* Four in ten (40.5%) patients in the cohort presented with symptoms of subacute (15-28 days) or chronic (>28 days) limb ischemia, a marked difference from previous studies of pharmacomechanical or aspiration peripheral arterial thrombectomy limited to ≤14-day limb ischemia.1-3