Surmodics’ Pounce XL Thrombectomy System Cleared by FDA

October 1, 2024—Surmodics, Inc. announced it has received FDA 510(k) clearance for its Pounce XL thrombectomy system. The company expects to initiate a limited market release for Pounce XL in the first half of 2025. Full commercialization is planned after the completion of the limited market release.

According to the company, the Pounce XL device is indicated for the nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5 to 10 mm in diameter, making it suitable for iliac, femoral, and other arteries within this range.

Surmodics stated that Pounce XL increases the size range of the company’s Pounce thrombectomy platform, which also includes the Pounce thrombectomy system, indicated for 3.5- to 6-mm peripheral arteries, and the low-profile Pounce LP thrombectomy system, indicated for 2- to 4-mm peripheral arteries. The Pounce device was introduced in 2021, and Pounce LP was introduced in 2024.

The three Pounce systems are fully mechanical thrombectomy devices designed to promptly remove organized thrombus or embolus without the need for thrombolytics, aspiration, or capital equipment. They are “grab-and-go” solutions, both readily deployable and simple to use, noted the company.

The systems are composed of a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered via the delivery catheter 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 With the clot entrained, the system is withdrawn into a minimum 7-F guide sheath through which the clot is removed from the body, stated Surmodics.

In the press release, Gary Maharaj, President and Chief Executive Officer of Surmodics, discussed the importance of the regulatory achievement for the company.

“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,” commented Mr. Maharaj. “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.”

Mr. Maharaj added, “Critically ischemic peripheral arteries often have older, organized clots that resist catheter-directed thrombolysis and aspiration thrombectomy. The Pounce thrombectomy platform allows physicians to rapidly restore blood flow regardless of clot morphology, which has the potential to reduce the need for follow-up procedures and additional thrombolytic therapy requiring intensive care unit admission.”