The system is designed to assist the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature
Surmodics, a medical device and in vitro diagnostic technologies provider, has received US Food and Drug Administration (FDA) 510(k) approval for its Pounce thrombus retrieval system.
The Pounce thrombus retrieval system is designed to assist the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
In May 2018, the medical device maker has acquired the technology and intellectual property related to Pounce thrombus retrieval system from Embolitech, a medical technology company that develops and manufactures intravascular systems.
Embolitech founder and former chief medical officer Gary Ansel said: “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.
“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.”
Pounce thrombus retrieval system is a mechanical thrombectomy device
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 device contains three components, including a 5 Fr basket delivery catheter, a basket wire assembly, and a trumpet assembly.
The basket wire assembly is delivered to the location of the thrombus, followed by two nitinol self-expanding baskets deployed to collect and entrain the clot into a trumpet-shaped nitinol wire mesh.
The trumpet assembly then collapses into a 7 Fr guide sheath through which the free clot is withdrawn and removed from the body.
Surmodics president and chief executive officer Gary Maharaj said: “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).
“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.”