Surmodics Pounce LP Thrombectomy System Cleared by FDA

June 14, 2023—Surmodics, Inc. announced it has received FDA 510(k) clearance for its Pounce LP (low-profile) thrombectomy system. The company expects to initiate a 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 after completion of the LME.

According to Surmodics, the Pounce thrombectomy system, which was introduced in 2021, is intended for the nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 to 6 mm in diameter. The Pounce LP, a new addition to the Pounce platform, is indicated for use in vessels ranging from 2 to 4 mm in diameter, sizes typical of vessels found below the knee.

The Pounce mechanical thrombectomy device is designed to promptly remove organized thrombus or embolus without the need for capital equipment, thrombolytics, or aspiration.

The system is composed of three components: a 5-F delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7-F guide sheath through which the clot is removed from the body, noted the company.

Gary Maharaj, President and CEO of Surmodics, stated in the company’s press release, “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.”

Mr. Maharaj continued, “Catheter-directed thrombolysis in these vessels is limited against organized clot and requires intensive care unit admission, while small-diameter aspiration thrombectomy devices may struggle to remove organized material in the distal lower extremity. By expanding the treatment range of the Pounce platform, we are addressing tibial clots, an important component of treatment in this vulnerable patient population, which fills a gap in care.”

Mr. Maharaj added, “FDA clearance of the Pounce LP thrombectomy system brings us one step closer to providing the complete mechanical thrombectomy solution for all peripheral arteries and demonstrates our commitment to leadership in this critical-needs space.”