Surmodics Touts Pounce Thrombectomy System Trial Results

Surmodics Inc.’s Pounce Thrombectomy System achieved 100 percent technical success in 20 First-in-Human (FIH) procedures, according to the company. 
 
Technical success was defined as the removal of clot to restore blood flow without the use of an additional adjunct thrombectomy device. Dr. Gary Ansel, inventor of the Pounce Thrombectomy System and a Surmodics consultant, revealed that 19 of the 20 procedures avoided 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 U.S. Food and Drug Administration-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, D.O., 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.
 
“The Pounce Thrombectomy System has the potential to revolutionize the treatment algorithm for arterial thrombectomy,” said Gary Maharaj, Surmodics CEO. “By providing peripheral interventionalists with an innovative, non-surgical tool for treating arterial thrombotic occlusions with a single session device designed to achieve an on-table result, this device will serve an important clinical need while advancing therapies for PAD.”
 
The Pounce Thrombectomy device is comprised of three components: a 5 Fr 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 Fr guide sheath through which the clot is withdrawn and removed from the body.
 
Worldwide, more than 200 million people have PAD,¹ a serious and underdiagnosed circulatory condition caused by build-up of arterial plaque, most commonly in the legs. Twelve to 20 percent of Americans over 60 years old have PAD,² which increases risk of coronary artery disease, heart attack and stroke, and can impair the ability to walk. If left untreated, PAD can lead to gangrene and limb amputation.³ The five-year mortality rate after nontraumatic major amputations of the lower extremity is estimated to range from 52 percent to 80 percent.⁴
 
Surmodics provides surface modification technologies for intravascular medical devices and chemical components for in-vitro diagnostic immunoassay tests and microarrays. Surmodics is pursuing development and commercialization of highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development, and manufacturing capabilities. Surmodics is headquartered in Eden Prairie, Minn. 
 
References
¹ Fowkes FG, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40.
² Centers for Disease Control and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.
³ National Institutes of Health. What is Peripheral Artery Disease? n.d. Web.
⁴ Thorud JC, Plemmons B, et al. Mortality After Nontraumatic Major Amputation Among Patients With Diabetes and Peripheral Vascular Disease: A Systematic Review. J Foot Ankle Surg. 2016 May-June; 55(3):591-9.