FDA gives Surmodics clearance for Pounce XL Thrombectomy System

Surmodics announced it has received U.S. Food and Drug Administration FDA 510(k) clearance for its Pounce XL Thrombectomy System…”Securing FDA clearance for the Pounce XL Thrombectomy System is a major step forward in Surmodics’ pursuit of a complete mechanical thrombectomy solution for all peripheral arteries, notably critically ischemic lower extremity vessels,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “The Pounce Thrombectomy Platform has already demonstrated its performance as a rapid, efficient solution for the removal of both acute and chronic thrombi and emboli in peripheral arteries without the use of thrombolytics…” Surmodics expects to initiate limited market release for the Pounce XL Thrombectomy System in the first half of 2025, with commercialization planned following the completion of the limited market release.