Surmodics Receives the US FDA’s 510(k) Clearance for Pounce LP Thrombectomy System
Shots:
- The US FDA has granted 510(k) clearance for Pounce LP (Low Profile) Thrombectomy System, a mechanical thrombectomy device developed for the non-surgical removal of thrombi & emboli i.e., efficient clot removal in below-the-knee peripheral arteries (2-4mm) without requiring any capital equipment for operation
- The system is designed for use in vessels ranging from 3.5-6mm in diameter & consists of 3 components i.e., a 5 Fr delivery catheter, a basket wire & a funnel catheter
- The company is expected to initiate limited market evaluation (LME) for Pounce LP Thrombectomy System at the end of Q1’24 with commercialization planned upon completion of LME. In Apr 2023, the first patient enrolled in (PROWL) registry study using the Pounce Thrombectomy System
Ref: Businesswire | Image: Surmodics
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