The addition of a low-profile device to a Surmodics thrombectomy platform is reported to allow for efficient clot removal in peripheral arteries ranging from 2mm to 4mm.
EDEN PRAIRIE, Minn.—In January, Surmodics reported the successful early clinical use of its Pounce™ LP (Low Profile) Thrombectomy System, designed to address a critical unmet need by facilitating removal of thrombi and emboli below the knee.
The Pounce LP Thrombectomy System received U.S. Food and Drug Administration (FDA) clearance in June 2023. It is currently in limited market evaluation (LME), with full commercial launch planned following completion of the LME, Surmodics said in a release.
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 complements the original Pounce Thrombectomy System, introduced in 2021, which is indicated for use in vessels measuring 3.5mm to 6mm in diameter.
The addition of the new low-profile device to the Surmodics Pounce thrombectomy platform is reported to allow for efficient clot removal in peripheral arteries ranging from 2mm to 4mm—sizes typical of vessels found below the knee.
“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 organized thrombotic or embolic clots from the iliac arteries in the pelvis down to tibial vessels below the knee,” said Surmodics President and Chief Executive Officer Gary Maharaj, in a statement. “Downstream embolization 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 revascularization.”
Lucas Ferrer Cardona, M.D., a vascular surgeon with the Dell Seton Medical Center at the University of Texas Hospital in Austin, was reportedly the first physician to use the Pounce LP System, according to the release.
“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,” Cordona said in the release. “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 embolization. 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, M.D., a vascular surgeon at the Hospital of the University of Pennsylvania, has experience using the original Pounce System and is among several other satisfied early users of the Pounce LP System. She recently deployed the Pounce LP device to revascularize 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 in the release. “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.”
The Pounce System is reported to be the first mechanical thrombectomy device designed to remove acute-to-chronic thrombi and emboli in occluded peripheral arteries without the need for capital equipment or aspiration and minimizing the use of thrombolytics.
Described as a “grab-and-go” solution, the Pounce System is both readily deployable and simple to use, according to the release. The System is composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel.
With the clot entrained, the System is withdrawn into a minimum 7 Fr guide sheath, through which the clot is removed from the body. The Pounce Thrombectomy platform includes two different-sized devices: the original Pounce™ Thrombectomy System, indicated for use in peripheral arterial vessels 3.5mm to 6mm in diameter, and the Pounce LP (Low Profile) Thrombectomy System, indicated for use in peripheral arterial vessels 2mm to 4mm in diameter.