Fda Grants Surmodics 510(K) Clearance For Pounce™ Lp Thrombectomy System

Thursday, June 15, 2023

Surmodics, a renowned provider of medical device and in vitro diagnostic technologies, has recently announced that its Pounce™ LP (Low Profile) Thrombectomy System has received FDA 510(k) clearance. This clearance signifies that the system meets the necessary regulatory requirements to be marketed and sold in the United States. The Pounce LP Thrombectomy System is an advanced medical device that expands upon the capabilities of the existing Pounce platform. It is specifically designed for the non-surgical removal of thrombi and emboli from peripheral arterial vasculature, with a focus on vessels ranging from 2 mm to 4 mm in diameter, commonly found below the knee.

Gary Maharaj, the President and CEO of Surmodics, expressed great excitement regarding the FDA clearance of the Pounce LP Thrombectomy System. He emphasized that this innovative system addresses the existing treatment gap for removing organized thrombotic or embolic occlusions in smaller vessels located below the knee. By broadening the treatment range of the Pounce platform, Surmodics aims to provide a comprehensive mechanical thrombectomy solution for all peripheral arteries, catering to the critical needs of patients.

In terms of the timeline for market availability, Surmodics plans to initiate limited market evaluation (LME) for the Pounce LP Thrombectomy System by the end of the first quarter of fiscal 2024. Following the completion of the LME phase, the company will proceed with the commercialization of the system.

Pounce Thrombectomy System

The Pounce Thrombectomy System is distinguished as a "grab-and-go" solution, representing the first mechanical thrombectomy device that allows for the prompt removal of organized thrombus or embolus without the need for capital equipment, thrombolytics, or aspiration. It consists of a 5 Fr delivery catheter, a basket wire, and a funnel catheter. The system facilitates the deployment of nitinol self-expanding baskets, which capture and retract the clot into the collection funnel. The clot is subsequently removed from the body through a minimum 7 Fr guide sheath.

Acute Limb Ischemia (ALI)

Acute Limb Ischemia (ALI) refers to a sudden decrease in arterial perfusion to a limb, posing a significant threat to limb survival and requiring urgent evaluation and management. The Pounce Thrombectomy System effectively addresses ALI by providing an efficient solution for the removal of thrombi, which can be caused by cardiac dysrhythmia or pre-existing peripheral artery disease. ALI interventions can result in high amputation and mortality rates, underscoring the importance of innovative technologies in improving patient outcomes.

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