Surmodics announced in a press release that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (low profile) thrombectomy system.
Introduced in 2021, the Pounce thrombectomy system is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5mm to 6mm in diameter. The Pounce LP thrombectomy system, a new addition to the Pounce platform, is indicated for use in vessels ranging from 2mm to 4mm in diameter, sizes typical of vessels found below the knee.
“We are excited to secure [US] FDA clearance for the Pounce LP thrombectomy system, which will extend the range of treatment for our Pounce platform to include removal of organised thrombotic or embolic occlusions in smaller vessels below the knee,” said Gary Maharaj, president and chief executive officer of Surmodics. “Catheter-directed thrombolysis in these vessels is limited against organised clot and requires intensive care admission, while small-diameter aspiration thrombectomy devices may struggle to remove organised material in the distal lower extremity. By expanding the treatment range of the Pounce platform we are addressing tibial clots, an important component of treatment in this vulnerable patient population which fills a gap in care.”
Maharaj added, “[US] FDA clearance of the Pounce LP thrombectomy system brings us one step closer to providing the complete mechanical thrombectomy solution for all peripheral arteries and demonstrates our commitment to leadership in this critical-needs space.”
