Surmodics Secures FDA Clearance for Pounce XL Thrombectomy System to Treat Larger Peripheral Arteries

Surmodics, Inc. (Nasdaq: SRDX), a leader in medical device and in vitro diagnostic technologies, has announced that it has received FDA 510(k) clearance for its Pounce™ XL Thrombectomy System. The system is designed for non-surgical removal of thrombi and emboli from peripheral arteries ranging from 5.5–10 mm in diameter, making it suitable for arteries such as the iliac and femoral. This clearance expands the Pounce Thrombectomy Platform, which already includes the Pounce Thrombectomy System, intended for 3.5–6 mm arteries, and the Pounce LP (Low Profile) Thrombectomy System, designed for 2–4 mm arteries. The Pounce Thrombectomy System and Pounce LP were launched in 2021 and 2024, respectively.

Gary Maharaj, President and CEO of Surmodics, highlighted the significance of the FDA clearance, stating that the Pounce XL Thrombectomy System marks a significant advancement in providing a comprehensive thrombectomy solution for peripheral arteries, particularly in critically ischemic lower extremity vessels. He emphasized the platform’s effectiveness in removing acute and chronic thrombi and emboli without the need for thrombolytic drugs.

Maharaj also noted that the Pounce Thrombectomy Platform allows physicians to restore blood flow quickly, even in cases where clots are resistant to thrombolysis, potentially reducing the need for additional procedures or ICU admission. Surmodics plans to begin a limited market release of the Pounce XL Thrombectomy System in the first half of 2025, with full commercialization to follow.

The Pounce Thrombectomy Platform consists of three components: a delivery catheter, a basket wire, and a funnel catheter. The system operates mechanically to capture and remove clots from the body without requiring thrombolytics, aspiration, or capital equipment, providing a quick and efficient solution for treating peripheral artery thrombosis.