Vesalio Receives Two FDA 510(k) Clearances, Advancing Its Comprehensive Thrombectomy Platform with Aspiration Technology

PLANO, Texas, Nov. 18, 2025 /PRNewswire/ -- Vesalio, a leader in innovative thrombectomy solutions, today announced two new FDA 510(k) clearances for its aspiration devices, designed for peripheral and neurovascular applications. These clearances mark a key milestone in Vesalio's evolution toward providing a complete suite of thrombectomy products across multiple vascular territories.

By integrating aspiration technology with its flagship mechanical retrieval platform, powered by proprietary Drop Zone® and microfiltration technologies, Vesalio delivers a versatile armamentarium for efficient clot removal. This expanded portfolio builds on proven stent-based innovations such as NeVa®, enVast™, and pVasc®, which have demonstrated success across neuro, coronary, and peripheral anatomies and are already adopted in global markets.

“With these new aspiration clearances, we’re uniquely positioned to provide physicians broader options to address diverse clot morphologies, driving better patient outcomes in critical conditions like stroke, myocardial infarct, and acute limb ischemia,” said Steve Rybka, CEO of Vesalio. “We will continue to broaden our portfolio with advanced solutions, applying our expertise to transform outcomes in additional disease states to make a meaningful impact on patient lives.”

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