US-based medical device company Surmodics has received the US Food and Drug Administration (FDA) 510(k) approval for its Pounce Low Profile (LP) Thrombectomy System.

The Pounce Thrombectomy System was originally launched in 2021 for the non-surgical removal of thrombi and emboli from the peripheral arterial blood vessels, measuring 3.5mm to 6mm in diameter.

With the addition of the LP model to the Pounce platform, the system is indicated for use in vessels ranging from 2mm to 4mm in diameter, which are typically found 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 organized material in the distal lower extremity.

“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.”

According to Surmodics, its Pounce system is the first mechanical thrombectomy device designed to remove organised thrombus or embolus without the need for capital equipment, thrombolytics, or aspiration.

The system, which can be readily deployed and easily used, contains three primary components, a 5 Fr delivery catheter, a basket wire, and a funnel catheter.

The basket wire is delivered distal to the location of the thrombus.

It deploys two nitinol self-expanding baskets to capture the clot and are retracted into the nitinol collection funnel.

After the clot is entrained, the system will be withdrawn into a minimum 7 Fr guide sheath, through which the clot is removed from the body.

Surmodics aims to initiate a limited market evaluation (LME) for the Pounce LP Thrombectomy System by the end of the first quarter of its fiscal 2024.

The company plans to commercialise the system after completing the LME.

Maharaj added: “FDA clearance of the Pounce LP Thrombectomy System brings us one step closer to providing the complete mechanical thrombectomy solution for all peripheral arteries and demonstrates our commitment to leadership in this critical-needs space.”