Surgical Robotics Technology
Surmodics, Inc. has 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.”
* No patient data for the Pounce XL System was available from the LINC subset analysis.
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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.
Source: Surmodics, Inc.
