Surmodics Reports Successful Clinical Use of its Pounce XL Thrombectomy System

Surmodics Inc. is touting the successful early clinical use of its Pounce XL Thrombectomy System, a solution that received U.S. Food and Drug Administration (FDA) 510(k) clearance in September 2024 and is currently in limited market release.

“We’re excited about the positive feedback we’ve received from early users of the Pounce XL System,” Surmodics President/CEO Gary Maharaj said. “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.”

Surmodics Pounce Thrombectomy systems are used to non-surgically remove thrombi and emboli from the peripheral arterial vasculature. The new Pounce XL Thrombectomy System is indicated for use in vessels ranging from 5.5 mm to 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 (Erie, Pa.) Hamot vascular surgeon Dr. Walter Rizzoni used the Pounce XL Thrombectomy System for the first time to restore blood flow in an 8 mm-diameter thrombosed stent graft.

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

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 mm to 6 mm, 2 mm to 4 mm, and 5.5 mm to 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 thrombus location, 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.

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 Jan. 29, 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 two to three procedural flow restoration, with 79.7% of subjects not receiving additional thromboemboli removal treatment post Pounce or Pounce LP System use.* Four in 10 (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

Surmodics provides performance coating technologies for intravascular medical devices and chemical and biological components for in-vitro diagnostic immunoassay tests and microarrays. Surmodics also develops and commercializes highly differentiated vascular intervention medical devices designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the company’s expertise in proprietary surface modification and drug-delivery coating technologies, along with its device design, development, and manufacturing capabilities. The Eden Prairie, Minn.-based company aims to improve disease detection and treatment.

* No patient data for the Pounce XL System was available from the LINC subset analysis.

References
¹ Leung DA, Blitz LR, Nelson T, et al. Rheolytic pharmacomechanical thrombectomy for the management of acute limb ischemia: results from the PEARL registry. J Endovasc Ther. 2015;22(4):546-557.
² Maldonado TS, Powell A, Wendorff H, et al. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024;79(3):584-592.
³ de Donato G, Pasqui E, Sponza M, et al. Safety and efficacy of vacuum assisted thrombo-aspiration in patients with acute lower limb ischaemia: the INDIAN trial. Eur J Vasc Endovasc Surg. 2021;61(5):820-828.