Surmodics (Nasdaq:SRDX) today announced the successful early clinical use of its Pounce XL thrombectomy system.
The early use comes as part of a limited market release. Surmodics plans for a full commercial launch planned for after the initial rollout. Pounce XL received FDA 510(k) clearance in September 2024. Dr. Walter Rizzoni used the system to restore blood flow in a thrombosed stent graft 8 mm in diameter. The case took place at the University of Pittsburg Medical Center (UPMC) Hamot in Erie, Pennsylvania.
“The Pounce XL thrombectomy system removed a significant amount of chronic material during our first use,” said Rizzoni. “In that respect, its performance was right in line with our experience using the Pounce and Pounce LP systems.”
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.
“We’re excited about the positive feedback we’ve received from early users of the Pounce XL System,” said Gary Maharaj, president and CEO. “The addition of this larger-profile device to the Pounce thrombectomy platform fulfills our goal of providing physicians a standalone solution for rapid removal of acute or chronic peripheral arterial clot throughout the lower extremity. With hospitals under growing pressure to reduce costs, we believe the standalone Pounce thrombectomy platform may help reduce the need for hospitalizations and follow-up procedures.”
More about the Surmodics Pounce platform
Eden Prairie, Minnesota-based Surmodics designed Pounce to enable physicians to rapidly restore blood flow regardless of clot morphology. Its fully mechanical thrombectomy devices can promptly remove organized thrombus or embolus. They don’t require thrombolytics, aspiration, or capital equipment.
Pounce XL 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 received FDA clearance in June 2023.
Surmodics describes Pounce systems as “grab-and-go” solutions, deployable and simple to use. Each system features a delivery catheter, a basket wire and a funnel catheter. The basket wire deploys two nitinol self-expanding baskets, which capture the clot before retracting into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body.
