Surmodics' Pounce XL Thrombectomy System Receives FDA Clearance
Key Insights
Surmodics (search) has received FDA 510(k) clearance for its Pounce XL Thrombectomy (search) System, expanding its Pounce platform for peripheral artery thrombus removal.
The Pounce XL is designed for use in 5.5–10mm diameter vessels, including iliac and femoral arteries, addressing a broader range of vessel sizes.
Surmodics (search) plans a limited market release in the first half of 2025, aiming to provide a comprehensive mechanical thrombectomy (search) solution without thrombolytics.
Surmodics (search) has announced FDA 510(k) clearance for its Pounce XL Thrombectomy (search) System, designed for the non-surgical removal of thrombi (search) and emboli (search) from peripheral arterial vasculature. This expansion of the Pounce platform addresses vessels 5.5–10mm in diameter, including iliac and femoral arteries, offering a solution for a broader range of vessel sizes.
The Pounce XL Thrombectomy (search) System complements Surmodics (search)' existing Pounce Thrombectomy System (3.5–6mm) and Pounce Low Profile (LP) Thrombectomy System (2–4mm), both introduced in recent years. The Pounce platform aims to provide a comprehensive mechanical thrombectomy solution for various peripheral artery sizes.
Addressing Critical Limb Ischemia
Gary Maharaj, president and CEO of Surmodics (search), emphasized the significance of this clearance: "Securing FDA clearance for Pounce XL is a major step forward in Surmodics’ pursuit of a complete mechanical thrombectomy (search) solution for all peripheral arteries, notably critically ischemic lower extremity vessels." Critical limb ischemia (search) often involves older, organized clots resistant to thrombolysis and aspiration thrombectomy.
Potential Benefits of the Pounce Platform
The Pounce platform allows physicians to rapidly restore blood flow regardless of clot morphology, potentially reducing the need for follow-up procedures and thrombolytic therapy requiring intensive care unit admission. This is particularly relevant for patients with chronic thrombi (search) and emboli (search) in peripheral arteries.
Market Release
Surmodics (search) anticipates a limited market release for the Pounce XL Thrombectomy (search) System in the first half of 2025, with full commercialization planned after the initial release phase.