Surmodics has announced the successful early clinical use of its Pounce XL thrombectomy system. The device received US Food and Drug Administration (FDA) 510(k) clearance in September 2024, and is currently in limited market release (LMR), with full commercial launch planned following completion of the LMR.
A press release notes that Surmodics Pounce thrombectomy systems are intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. The new Pounce XL thrombectomy system is indicated for use in vessels ranging from 5.5–10mm in diameter, sizes typical of iliac and femoral arteries. The Pounce XL system complements the Pounce and Pounce LP thrombectomy systems, which are indicated for 3.5–6mm and 2–4mm vessels, respectively.
Walter Rizzoni (University of Pittsburg Medical Center [UPMC] Hamot, Erie, USA) successfully used the new Pounce XL thrombectomy system to restore blood flow in a thrombosed stent graft 8mm in diameter. This marks Rizzoni’s first case using the device at UPMC Hamot.
“The Pounce XL thrombectomy system removed a significant amount of chronic material during our first use,” said Rizzoni. “In that respect, its performance was right in line with our experience using the Pounce and Pounce LP systems.”
“We’re excited about the positive feedback we’ve received from early users of the Pounce XL system,” said Gary Maharaj, president and chief executive officer of Surmodics. “The addition of this larger-profile device to the Pounce thrombectomy platform fulfils our goal of providing physicians a standalone solution for rapid removal of acute or chronic peripheral arterial clot throughout the lower extremity. With hospitals under growing pressure to reduce costs, we believe the standalone Pounce thrombectomy platform may help reduce the need for hospitalisations and follow-up procedures.”
