FDA OKs Surmodics’ Pounce Thrombus Retrieval System

Surmodics Inc., a provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce Thrombus Retrieval System.
 
The Pounce Thrombus Retrieval System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. Depending on the age and magnitude of the occlusion and the viability of the threatened limb, existing treatments for this condition may include catheter directed thrombolysis, surgical embolectomy, and/or percutaneous mechanical thrombectomy. In cases in which the occlusion has caused irreversible damage to the limb, acute limb ischemia can result in the amputation of a lower extremity.
 
The Pounce Thrombus Retrieval System is a mechanical thrombectomy device that facilitates thrombus removal in peripheral vasculature without the added expense or commitment to any additional, external capital equipment.
 
“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 (PAD),” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “This approval also demonstrates Surmodics’ deep R&D capabilities and we are excited to ramp up our development efforts on new clinical applications for deep vein thrombosis (DVT), pulmonary embolism (PE) and ischemic stroke.”
 
The device is comprised of three components: a 5 Fr basket delivery catheter, a basket wire assembly, and a trumpet assembly. 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 With the clot entrained, the trumpet assembly is then collapsed into a 7 Fr guide sheath through which the clot is withdrawn and removed from the body.
 
“The Surmodics team has done an excellent job finalizing 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, ” said Gary Ansel, MD, 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, non-surgical 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.”