Pounce Thrombectomy System First-in-Human Data Show 100 Percent Technical Success in Early Cases

Surmodics, Inc. (NASDAQ : SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced today that its Pounce Thrombectomy System achieved 100 percent technical success in 20 First-in-Human (FIH) procedures. The FIH data was presented Tuesday by Dr. Gary Ansel at the Charing Cross International Symposium in London.

Technical success was defined as the removal of clot to restore blood flow without the use of an additional adjunct thrombectomy device. Ansel, the inventor of the Pounce Thrombectomy System and a consultant for Surmodics, also revealed that 19 of the 20 procedures were able to avoid the use of thrombolytics in the target lesion. The FIH cases were performed across six U.S. medical centers, with the first use of the FDA-cleared system occurring in June 2021.

“The Pounce Thrombectomy System demonstrated technical success in these early clinical cases, showing an ability to quickly deal with a wide range of clot from soft to organized, including emboli in the peripheral arterial vasculature,” said Ansel. “This fully mechanical thrombectomy device has no power unit or other capital equipment requirement, making it easy to use and efficient for physicians to treat patients with complex peripheral artery disease (PAD).”

Average procedure time in the FIH cases was 79.6 minutes and the average lesion length measured 109 mm (range 5-300 mm). Clinical presentation time ranged from one hour to eight months, with 30 percent of cases involving acute on chronic clot. Chronic clot (25 percent), acute clot (25 percent) and subacute (15 percent) was also removed. Five percent of cases did not indicate clot classification. The superficial femoral artery was the most common vessel treated (50 percent) while 40 percent of the cases involved the popliteal artery.

“I appreciate the ease of use, the avoidance of thrombolytic therapy, and the ability to rapidly resolve limb ischemia,” said Dr. Bruce Gray, DO, MSVM, a physician who performed cases included in the FIH data. “These characteristics make it my go-to strategy to treat acute limb ischemia. It takes only one case to realize the profound impact the Pounce Thrombectomy System provides to patients.”

The intuitive ‘grab and go’, non-aspiration, mechanical thrombectomy solution empowers physicians to strike quickly to capture and remove clot from the peripheral vasculature without requiring external capital equipment for operation. The Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature.