Surmodics Receives FDA Clearance for Thrombectomy System

By Will Feuer

Medical-device maker Surmodics said it has received clearance from the U.S. Food and Drug Administration for its Pounce Low Profile Thrombectomy System.

The Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 mm to 6 mm in diameter, the company said.

The low-profile system is indicated for use in vessels ranging from 2 mm to 4 mm in diameter, sizes typical of vessels found below the knee.

Surmodics said it expects to initiate limited market evaluation for the Pounce LP Thrombectomy System by the end of the first quarter of its fiscal 2024, or around December of this year. The company plans to commercialize the system following the limited market evaluation.

Chief Executive Gary Maharaj said the new system would extend the range of treatment for the Pounce platform to include removal of organized thrombotic or embolic occlusions in smaller vessels below the knee.

Write to Will Feuer at Will.Feuer@wsj.com

(END) Dow Jones Newswires

June 14, 2023 08:16 ET (12:16 GMT)

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