FDA OKs Surmodics’ Pounce XL Thrombectomy System

Surmodics has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce XL thrombectomy system.
 
Pounce XL is indicated to non-surgically remove thrombi and emboli from peripheral arterial vasculature in vessels 5.5-10 mm in diameter. This makes it suitable for iliac, femoral, and other arteries in this range.
 
The new product increases the Pounce platform’s size range. The platform includes the Pounce thrombectomy platform, which is indicated for 3.5-6 mm peripheral arteries, and Pouce LP (low profile) for 2-4 mm peripheral arteries. Pounce and Pounce LP were introduced in 2021 and 2024, respectively.
 
Surmodics anticipates releasing Pounce XL on a limited basis in the first half of 2025, with full commercialization to follow.
 
“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.”

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FURTHER READING: Private Equity Firm to Buy Surmodics for $627M

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More about the Pounce thrombectomy platform

Pounce, Pounce LP, and Pounce XL are fully mechanical thrombectomy devices to quickly remove organize thrombus or embolus without the need for thrombolytics, aspiration, or capital equipment.
 
The systems are made of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered via the delivery catheter distal to the thrombus location, 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With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body.