Surmodics granted FDA nod for Pounce LP clot removal system

• Surmodics (NASDAQ:SRDX) announced Wednesday that the FDA granted 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System, expanding the addressable market for the clot removal device.
• The company launched Pounce Thrombectomy System in 2021 to remove thrombi and emboli from peripheral arterial vessels with 3.5 mm - 6 mm in diameter.
• Following 510(k) clearance, the newly-added Pounce LP system will be indicated for clot removal in peripheral arteries ranging from 2 mm - 4 mm in diameter, mostly found below the knee.
• “By expanding the treatment range of the Pounce platform we are addressing tibial clots, an important component of treatment in this vulnerable patient population which fills a gap in care,” CEO of Surmodics (SRDX) Gary Maharaj remarked.
• The company plans to launch Pounce LP after a limited market evaluation (LME) for the device expected before the year-end.

More on Surmodics

• Surmodics upgraded at Needham citing FDA nod for drug coated balloon
• Surmodics stock surges 10% on FDA feedback for drug-coated balloon filing