Surmodics gets FDA clearance for Pounce Thrombectomy System

Surmodics announced it has received U.S. Food and Drug Administration clearance for its Pounce 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. “We are excited to secure FDA clearance for the Pounce LP Thrombectomy System, which will extend the range of treatment for our Pounce platform to include removal of organized thrombotic or embolic occlusions in smaller vessels below the knee,” said Gary Maharaj, President and Chief Executive Officer of Surmodics…Surmodics expects to initiate limited market evaluation for the Pounce LP Thrombectomy System by the end of the first quarter of its fiscal 2024 with commercialization planned following completion of the LME.