Surmodics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Pounce LP (Low Profile) Thrombectomy System.
The system, which was launched in 2021, is designed to non-surgically remove thrombi and emboli from the peripheral arterial vasculature in 3.5mm to 6mm diameter vessels.
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The latest addition to the Pounce platform, the new Pounce LP Thrombectomy System has been developed for use in vessels ranging from 2mm to 4mm in diameter.
Vessels of this size are generally located below the knee.
Surmodics president and CEO Gary Maharaj said: “We are excited to secure FDA clearance for the Pounce LP Thrombectomy System, which will extend the range of treatment for our Pounce platform to include removal of organised thrombotic or embolic occlusions in smaller vessels below the knee.
“Catheter-directed thrombolysis in these vessels is limited against organised clot and requires ICU admission while small-diameter aspiration thrombectomy devices may struggle to remove organised material in the distal lower extremity.”
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By GlobalDataSurmodics intends to begin limited market evaluation (LME) for the system by the end of fiscal 2024’s first quarter.
After the completion of the LME, the company will start its commercialisation.
The Pounce system is claimed to be the first mechanical thrombectomy device that can remove organised thrombus or embolus without using capital equipment, thrombolytics or aspiration.
It features a 5 Fr delivery catheter, a funnel catheter and a basket wire.
In April this year, Surmodics enrolled the first patient in the PROWL registry study designed to assess the effectiveness of the Pounce Thrombectomy System.
