Surmodics (Nasdaq:SRDX) announced today that it received FDA 510(k) clearance for its Pounce XL thrombectomy system.
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.
Pounce XL dramatically 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 receiving FDA clearance in June 2023.
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 without the need for thrombolytics, aspiration, or capital equipment.
The company describes them as “grab-and-go” solutions. Pounce systems feature a delivery catheter, a basket wire and a funnel catheter. They deploy two nitinol self-expanding baskets, which capture the clot and retract 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 With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath, through which the clot is removed from the body.
Eden Prairie, Minnesota–based Surmodics — which earlier this year agreed to be acquired by GTCR, a private equity firm with healthcare interests — plans to roll out Pounce XL in a limited launch during the first half of 2025. It then plans for full commercialization upon the conclusion of the limited release.
“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 CEO 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. The addition of the Pounce XL thrombectomy system to our Pounce thrombectomy platform demonstrates our commitment to setting the pace and direction of innovation in this critical space.”
