SurModics has secured 510(k) from the US Food and Drug Administration (FDA) for its Pounce LP (Low Profile) Thrombectomy System.
The thrombectomy system was launched in 2021 and is designed to non-surgically remove thrombi and emboli from the peripheral arterial vasculature in 3.5mm to 6mm diameter vessels.
To learn more about how the miracle treatment that has seen some stroke patients walk out of the hospital the day after their stroke works, read our article with thrombectomy expert Dr Sanjeev Nayak, here.
The Pounce LP Thrombectomy System is the latest edition to the pounce platform and 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. 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.
“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.”
Surmodics intends to begin limited market evaluation for the system by the end of fiscal 2024’s first quarter.
Upon completion of the limited market evaluation, the company will start its commercialisation.
It is claimed that the Pounce System is claimed to be the first mechanical thrombectomy device which has the capability to remove organised thrombus or embolus without the use of capital equipment, thrombocytes or aspiration.
The thrombectomy system features a 5 Fr delivery catheter, a funnel catheter and a basket wire.
Earlier this year, Surmodics enrolled the first patient in the PRWOL registry study designed to assess the effectiveness of the Pounce Thrombectomy System.
