Surmodics, Inc. announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Introduced in 2021, the Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 mm to 6 mm in diameter. The Pounce LP Thrombectomy System, a new addition to the Pounce platform, is indicated for use in vessels ranging from 2 mm to 4 mm in diameter, sizes typical of vessels found below the knee.

Surmodics expects to initiate limited market evaluation (LME) for the Pounce LP Thrombectomy System by the end of the first quarter of its fiscal 2024 (ending December 2023), with commercialization planned following completion of the LME.