Surmodics’ Pounce Thrombectomy System Shows 100% Technical Success in FIH Data Procedures

April 27, 2022—Surmodics, Inc. announced that data from the 20 first-in-human (FIH) procedures using the company’s FDA-cleared Pounce thrombectomy system to treat peripheral artery disease (PAD) were presented by Gary Ansel, MD, the inventor of the Pounce device, at the Charing Cross International Symposium 2022 held April 26-28 in London, United Kingdom.

According to the company, Dr. Ansel reported that the device achieved 100% technical success, defined as the removal of clot to restore blood flow without the use of an additional adjunct thrombectomy device. Additionally, 19 of the 20 FIH procedures were able to avoid the use of thrombolytics in the target lesion.

The FIH cases were performed at six medical centers in the United States beginning in June 2021. The company reported on the initial cases in July 2021.

As summarized in the company’s press release, the 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 1 hour to 8 months.

The cases involved acute-on-chronic clot (30%), chronic clot (25%), acute clot (25%), and subacute clot (15%); 5% of cases did not indicate clot classification. The superficial femoral artery was the most common vessel treated (50%), and 40% of the cases involved the popliteal artery.

In September 2020, Surmodics announced FDA 510(k) clearance for the Pounce mechanical thrombectomy device for the nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature.

“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,” commented Dr. Ansel in the Surmodics press release. “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 PAD.”

Bruce Gray, DO, who performed cases included in the FIH data, added, “I appreciate the ease of use, the avoidance of thrombolytic therapy, and the ability to rapidly resolve limb ischemia. 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.”

Surmodics noted that the Pounce thrombectomy device is composed of a 5-F 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 a nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7-F guide sheath through which the clot is withdrawn and removed from the body.

The intuitive grab-and-go, nonaspiration, mechanical thrombectomy solution allows physicians to quickly capture and remove clot from the peripheral vasculature without requiring external capital equipment for operation, stated the company.