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Surmodics' Pounce XL Thrombectomy System Shows Promise in First Clinical Case

• Surmodics successfully completed the first clinical use of its Pounce XL thrombectomy system at UPMC Hamot, effectively removing chronic thrombus from an 8mm stent graft.

• The FDA-cleared Pounce XL system, designed for vessels 5.5-10mm in diameter, expands Surmodics' thrombectomy platform portfolio for comprehensive peripheral arterial clot removal.

• The standalone mechanical system requires no thrombolytics or capital equipment, potentially reducing hospitalization costs and follow-up procedures.

In a significant advancement for peripheral vascular intervention, Surmodics has announced the successful first clinical use of its Pounce XL thrombectomy system as part of its limited market release program. The procedure, performed by Dr. Walter Rizzoni at the University of Pittsburgh Medical Center (UPMC) Hamot in Erie, Pennsylvania, demonstrated the system's effectiveness in restoring blood flow in a thrombosed stent graft measuring 8mm in diameter.

Clinical Performance and System Capabilities

"The Pounce XL thrombectomy system removed a significant amount of chronic material during our first use," reported Dr. Rizzoni, noting that the performance aligned with previous experiences using other devices in the Pounce family. The system, which received FDA 510(k) clearance in September 2024, is specifically indicated for non-surgical removal of thrombi and emboli from peripheral arterial vasculature in vessels ranging from 5.5 to 10mm in diameter.

Technical Innovation in Thrombectomy

The Pounce XL system represents an expansion of Surmodics' comprehensive thrombectomy platform. The technology employs a sophisticated design featuring three key components: a delivery catheter, a basket wire, and a funnel catheter. The mechanism of action involves two self-expanding nitinol baskets that capture clots before retracting them into a nitinol collection funnel, allowing for removal through a minimum 7 Fr guide sheath.

Market Impact and Healthcare Economics

Gary Maharaj, president and CEO of Surmodics, emphasized the strategic importance of this larger-profile device: "The addition of this larger-profile device to the Pounce thrombectomy platform fulfills our goal of providing physicians a standalone solution for rapid removal of acute or chronic peripheral arterial clot throughout the lower extremity."
The system's standalone mechanical nature, requiring no thrombolytics, aspiration, or capital equipment, positions it as a potentially cost-effective solution for healthcare providers. This aspect is particularly relevant given increasing pressure on hospitals to reduce costs while maintaining effective patient care.

Portfolio Expansion

The Pounce platform now offers a comprehensive solution set for various vessel sizes:
  • Pounce XL: For vessels 5.5-10mm in diameter
  • Standard Pounce: For 3.5-6mm peripheral arteries
  • Pounce LP (low-profile): For 2-4mm peripheral arteries
This strategic portfolio development, with the LP version receiving FDA clearance in June 2023, demonstrates Surmodics' commitment to addressing the full spectrum of peripheral vascular intervention needs.
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