US-based medical device company Surmodics has secured the US Food and Drug Administration (FDA) 510(k) clearance for its Pounce Thrombus Retrieval System.
The mechanical thrombectomy device is developed for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.
It is designed to enable thrombus removal in the peripheral vasculature, eliminating the need for added expense or commitment to any external capital equipment.
Surmodics president and CEO 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.”
Pounce Thrombus Retrieval System features three components: a five Fr basket delivery catheter, a basket wire assembly and a trumpet assembly.
The basket wire assembly will deliver distal to the location of the thrombus, while two nitinol self-expanding baskets will collect and entrain the clot into a trumpet-shaped nitinol wire mesh.
The trumpet assembly is then collapsed into a seven Fr guide sheath, through which the clot is withdrawn and removed from the body.
Surmodics acquired the technology and intellectual property for the Pounce Thrombus Retrieval System from Embolitech in 2018.
Commenting on the development, Embolitech founder and former chief medical officer Gary Ansel said: “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.
“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.”
The current treatments peripheral arterial vasculature may include catheter-directed thrombolysis, surgical embolectomy, and / or percutaneous mechanical thrombectomy, based on the age and magnitude of the occlusion and the viability of the threatened limb.
Acute limb ischemia may lead to amputation of a lower extremity in cases, in which the occlusion has induced irreversible damage to the limb.