Sam Brusco, Associate Editor06.14.23
Surmodics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (low-profile) thrombectomy system.
The original Pounce thrombectomy system was introduced in 2021. It’s meant for non-surgical removal of thrombi and emboli from peripheral arterial vasculature in vessels 3.5 to 6 mm in diameter. Pounce LP is indicated for use in vessels ranging from 2 to 4 mm in diameter, which are typical vessel sizes found below the knee.
“We are excited to secure FDA clearance for the Pounce LP Thrombectomy System, which will extend the range of treatment for our Pounce platform to include removal of organized thrombotic or embolic occlusions in smaller vessels below the knee,” Gary Maharaj, president and CEO of Surmodics told the press. “Catheter-directed thrombolysis in these vessels is limited against organized clot and requires ICU admission, while small-diameter aspiration thrombectomy devices may struggle to remove organized 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, “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.”
Surmodics aims to begin limited market evaluation for Pounce LP by the end of its Q1 2024 (ended December 2023), with commercialization planned following its completion.
In April, Surmodics began its PROWL retrospective registry study to gather real-world data for endovascular interventions using the Pounce thrombectomy system.
The original Pounce thrombectomy system was introduced in 2021. It’s meant for non-surgical removal of thrombi and emboli from peripheral arterial vasculature in vessels 3.5 to 6 mm in diameter. Pounce LP is indicated for use in vessels ranging from 2 to 4 mm in diameter, which are typical vessel sizes found below the knee.
“We are excited to secure FDA clearance for the Pounce LP Thrombectomy System, which will extend the range of treatment for our Pounce platform to include removal of organized thrombotic or embolic occlusions in smaller vessels below the knee,” Gary Maharaj, president and CEO of Surmodics told the press. “Catheter-directed thrombolysis in these vessels is limited against organized clot and requires ICU admission, while small-diameter aspiration thrombectomy devices may struggle to remove organized 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, “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.”
Surmodics aims to begin limited market evaluation for Pounce LP by the end of its Q1 2024 (ended December 2023), with commercialization planned following its completion.
In April, Surmodics began its PROWL retrospective registry study to gather real-world data for endovascular interventions using the Pounce thrombectomy system.