FDA clears Surmodics’ Pounce XL thrombectomy system

Surmodics (Nasdaq:SRDX) announced today that it received FDA 510(k) clearance for its Pounce XL thrombectomy system.

The FDA indicated Pounce XL for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter. That makes it suitable for iliac, femoral, and other arteries within this range.

Pounce XL dramatically increases the size range of Surmodics’ Pounce thrombectomy platform. The platform also includes the Pounce system for 3.5–6 mm peripheral arteries, and the Pounce LP (low-profile) for 2–4 mm peripheral arteries. Surmodics introduced those systems in 2021 and 2024, respectively. The LP version receiving FDA clearance in June 2023.

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