Surmodics Receives FDA 510(k) Clearance for Pounce™ XL Thrombectomy System, Expanding the Pounce Thrombectomy Platform to Larger Peripheral Arteries up to 10 mm in Diameter
The Pounce™ Thrombectomy Platform can now be used to remove clot from peripheral arteries as small as 2mm up to as large as 10 mm in diameter, broadening the platform's clinical utility and significantly expanding its addressable market
The Pounce XL Thrombectomy System is indicated for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter, making it suitable for iliac, femoral, and other arteries within this range. The Pounce XL Thrombectomy System dramatically increases the size range of the Pounce Thrombectomy Platform, which also includes the Pounce Thrombectomy System, indicated for 3.5–6 mm peripheral arteries, and the
“Securing FDA clearance for the Pounce XL Thrombectomy System is a major step forward in Surmodics’ pursuit of a complete mechanical thrombectomy solution for all peripheral arteries, notably critically ischemic lower extremity vessels,” said
About the Pounce Thrombectomy Platform
The Pounce Thrombectomy System, Pounce LP Thrombectomy System, and Pounce XL Thrombectomy System are fully mechanical thrombectomy devices designed to promptly remove organized thrombus or embolus without the need for thrombolytics, aspiration, or capital equipment. Described as “grab-and-go” solutions, Pounce Thrombectomy Platform devices are both readily deployable and simple to use. The systems are composed of three components: a delivery catheter, a basket wire, and a funnel catheter. The basket wire is delivered via the delivery catheter distal to the location of the thrombus, deploying two nitinol self-expanding baskets. The baskets capture the clot and are retracted into the nitinol collection funnel. With the clot entrained, the system is withdrawn into a minimum 7 Fr guide sheath through which the clot is removed from the body.
About Acute Limb Ischemia (ALI)
ALI is characterized by a sudden decrease in arterial perfusion to the limb, with a potential threat to limb survival, requiring urgent evaluation and management. Common causes include embolization due to cardiac dysrhythmia or thrombus from pre-existing peripheral artery disease.1 ALI is associated with 30-day amputation and mortality rates as high as 30% and 11.5%, respectively.2 ALI-related interventions may account for up to 16% of the case volume for vascular surgeons and be accompanied by hospitalization costs of
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Björck M, Earnshaw J, Acosta S, et al.
European Society for Vascular Surgery (ESVS) 2020 clinical practice guidelines on the management of acute limb Ischaemia. Eur J Vasc Endovasc Surg. 2020;59(2):173e218. - Gupta R, Siada SS, Bronsert M, Al-Musawi MH, Nehler MR, Jeniann AY. High Rates of Recurrent Revascularization in Acute Limb Ischemia–A National Surgical Quality Improvement Program Study. Ann Vasc Surg. 2022;87:334-342.
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Safe Harbor for Forward-Looking Statements
This press release contains forward-looking statements. Statements that are not historical or current facts, including statements regarding the Pounce XL Thrombectomy System significantly expanding its addressable market for the product platform, Surmodics’ pursuit of a complete mechanical thrombectomy solution for all peripheral arteries, Surmodics’ commitment to setting the pace and direction of innovation in mechanical thrombectomy solutions in peripheral arteries, expectations regarding the initiation of the limited market release and commercialization of the Pounce XL Thrombectomy System, and Surmodics’ growth strategy, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the willingness of Premier members to adopt use of the
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