Rachel Klemovitch06.15.23
Surmodics announced its FDA 510k clearance for its Pounce low-profile (LP) thrombectomy system.
The Pounce system was released in 2021 and was designed for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. It performs this removal in vessels between 3.5mm and 6mm in diameter.
Pounce LP is a new addition to the Pounce platform and treats vessels typically found below the knee, between 2mm and 4mm in diameter. The Pounce system features three components: a basket wire, a 5 Fr delivery catheter, and a funnel catheter.
The basket wire is delivered distal to the location of the thrombus and deploys two nitinol self-expanding baskets. The baskets capture the colt and retract into the nitinol collection funnel. The colt is removed through the body with it entrained, the system withdraws into a minimum 7 Fr guide sheath.
“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,” said President and CEO Gary Maharaj.
“Catheter- directed thrombolysis in these vessels is limited against organized clot and requires ICU admission, while smaller- 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.”
By the end of December 2023, Surmodics expects to hold a limited market evaluation for Pounce LP with plans for commercialization to follow the completion of that evaluation.
The Pounce system was released in 2021 and was designed for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. It performs this removal in vessels between 3.5mm and 6mm in diameter.
Pounce LP is a new addition to the Pounce platform and treats vessels typically found below the knee, between 2mm and 4mm in diameter. The Pounce system features three components: a basket wire, a 5 Fr delivery catheter, and a funnel catheter.
The basket wire is delivered distal to the location of the thrombus and deploys two nitinol self-expanding baskets. The baskets capture the colt and retract into the nitinol collection funnel. The colt is removed through the body with it entrained, the system withdraws into a minimum 7 Fr guide sheath.
“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,” said President and CEO Gary Maharaj.
“Catheter- directed thrombolysis in these vessels is limited against organized clot and requires ICU admission, while smaller- 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.”
By the end of December 2023, Surmodics expects to hold a limited market evaluation for Pounce LP with plans for commercialization to follow the completion of that evaluation.