Surmodics has announced successful early clinical use of the company’s Pounce LP (low-profile) thrombectomy system. The Pounce LP system, which received US Food and Drug Administration (FDA) clearance in June 2023, is currently in limited market evaluation (LME), with full commercial launch planned following completion of the LME.
Surmodics’ Pounce thrombectomy devices are intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. The new Pounce LP thrombectomy system is indicated for use in vessels ranging from 2–4mm in diameter, sizes typical of vessels found below the knee. A press release details that the Pounce LP system complements the original Pounce thrombectomy system, introduced in 2021, which is indicated for use in vessels 3.5–6mm in diameter.
Lucas Ferrer Cardona, a vascular surgeon with the Dell Seton Medical Center at the University of Texas Hospital in Austin, USA, was the first physician to use the Pounce LP system.
“In our first use of the device, the Pounce LP thrombectomy system performed exceptionally well in helping our team restore blood flow to the foot for a limb-threatened patient,” he said. “Using the device, we promptly removed acute and subacute thrombus from the mid-peroneal artery below the knee with no adjunctive use of thrombolytics and no embolisation. Thrombi or emboli in below-the-knee vessels have traditionally been very challenging to remove. I believe this device holds great promise in filling a major gap in our treatment algorithm.”
Elizabeth Genovese, a vascular surgeon at the Hospital of the University of Pennsylvania in Philadelphia, USA, who has experience using the original Pounce system, is among several other satisfied early users of the Pounce LP system. She recently deployed the Pounce LP device to revascularise a patient with arterial occlusions in both the anterior tibial and peroneal arteries.
“The Pounce LP system allowed me to treat chronic thrombus in these vessels with the effectiveness I’d expect from open surgical Fogarty embolectomy while maintaining the advantages of an endovascular approach for treating underlying and distal disease,” she said. “We were able to achieve an optimal outcome in a very complex lesion, and this type of result would not have been possible without this device.”
“We’re very pleased with the successful early clinical use of the Pounce LP thrombectomy system, which will extend the range of treatment for our Pounce platform to include removal of organised thrombotic or embolic clots from the iliac arteries in the pelvis down to tibial vessels below the knee,” said Gary Maharaj, president and chief executive officer of Surmodics. “Downstream embolisation of chronic material into below-the-knee arteries during an endovascular procedure can be an interventionist’s nightmare, sometimes requiring surgical rescue. The Pounce LP system’s ability to capture and remove these unexpected emboli adds yet more value to this device for BTK [below-the-knee] revascularisation.”
