Surmodics has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for its Pounce thrombus retrieval system.
The company describes the Pounce system as a mechanical thrombectomy device intended for the nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature without the added expense or commitment to additional external capital equipment. The device includes a 5Fr basket delivery catheter, a basket wire assembly, and a trumpet assembly. Its mechanism of action is described as follows: “After the basket wire assembly is delivered distal to the location of the thrombus, two nitinol self-expanding baskets are deployed to collect and entrain the clot into a trumpet-shaped nitinol wire mesh. With the clot entrained, the trumpet assembly is then collapsed into a 7Fr guide sheath through which the clot is withdrawn and removed from the body.”
“The Surmodics team has done an excellent job finalising the product design and advancing the Pounce thrombus retrieval system into a medical device that has the potential to change the treatment algorithm for arterial thrombectomy,” comments Gary Ansel (OhioHealth Heart & Vascular Physicians, Columbus, USA), founder and former chief medical officer of Embolitech, from which Surmodics acquired the technology and intellectual property behind the Pounce thrombus retrieval system. “By providing peripheral interventionalists with an innovative, nonsurgical tool for treating arterial thrombotic occlusions, the Pounce thrombus retrieval system will serve an important clinical need and is a great fit with the company’s focus on advancing therapies for peripheral artery disease.”
Surmodics president and CEO Gary Maharaj adds: “The FDA 510(k) clearance of our Pounce thrombus retrieval system brings us one step closer to providing a technology that offers significant advances over the current treatment of complex, peripheral artery disease.” Maharaj also noted the company’s development efforts in the areas of deep vein thrombosis, pulmonary embolism, and ischaemic stroke. The company recently announced CE Mark for its Surveil drug-coated balloon and FDA clearance of its Sublime radial access 0.014 RX PTA dilatation catheter.