Cleared by the FDA in June 2023, the Pounce LP Thrombectomy System is currently undergoing limited market evaluation
Surmodics has reported the positive early clinical use of its Pounce LP Thrombectomy System. (Credit: Narupon Promvichai from Pixabay)
Surmodics, a company specialising in medical device and in vitro diagnostic technologies, has reported positive early clinical use of its Pounce LP (Low Profile) Thrombectomy System.
Granted clearance by the US Food and Drug Administration (FDA) in June 2023, the Pounce LP Thrombectomy System is currently undergoing limited market evaluation (LME). A full commercial launch of the product is anticipated upon the completion of the LME phase.
According to Surmodics, its Pounce Thrombectomy devices are designed for the non-surgical extraction of thrombi and emboli from the peripheral arterial vasculature.
The first clinical use of the Pounce LP System was by Lucas Ferrer Cardona, a vascular surgeon affiliated with the Dell Seton Medical Center at the University of Texas Hospital in Austin.
Cardona said: “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.
“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.”
The newly introduced Pounce LP Thrombectomy System is specifically indicated for use in vessels with diameters ranging from 2mm to 4mm, which are sizes commonly found in vessels below the knee. This system complements the original Pounce Thrombectomy System, launched in 2021, which is intended for use in vessels with diameters ranging from 3.5mm to 6mm.
The Pounce System comprises three components, which are a delivery catheter, a basket wire, and a funnel catheter.
The basket wire is introduced distally to the thrombus location, deploying two nitinol self-expanding baskets. These baskets capture the clot and are then retracted into the nitinol collection funnel.
Once the clot is entrained, the entire system is withdrawn into a guide sheath with a minimum diameter of 7 Fr, facilitating the removal of the clot from the body.
Surmodics president and CEO Gary Maharaj said: “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.
“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 revascularisation.”