Surmodics Low Profile Thrombectomy System Cleared

FDA has cleared a Surmodics 510(k) for its Pounce LP (Low Profile) Thrombectomy System. The device was originally cleared in 2021 for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 mm to 6 mm in diameter, according to the company. The LP addition is intended for use in vessels ranging from 2 mm to 4 mm in diameter, sizes typical of vessels found below the knee, it says.

The device comprises three components: a 5 Fr delivery catheter, a basket wire, and a funnel catheter, Surmodics says. “The basket wire is delivered distal to the location of the thrombus, deploying two nitinol self-expanding baskets,” it explains. “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 With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body.”