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

The FDA clearances expand Vesalio's thrombectomy portfolio to support its growth strategy in the rapidly expanding multi-billion dollar global thrombectomy market.

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."

The approvals further advance Vesalio's vision of a fully integrated thrombectomy ecosystem, where mechanical retrieval and aspiration technologies work in synergy to enhance procedural efficiency and clinical success. This portfolio extension aligns with the company's strategy to expand its presence, driving sustainable growth in the rapidly growing global thrombectomy market.

About Vesalio 
Founded in 2017, Vesalio is a privately held medical device company focused on advancing patient care in thromboembolic vascular disease by providing physicians with superior technology for improving clinical outcomes. Vesalio's proprietary NeVa®, enVast™, and pVasc® platforms are designed to effectively remove all types of clots and restore vital blood flow to compromised ischemic tissue in the brain, heart, and peripheral anatomy. Vesalio's products have treated more than 15,000 patients in over 50 countries. For more information, visit www.vesalio.com.

Investor Contacts
Steve Rybka, CEO, Vesalio
[email protected]

J.D. McCulloch, CFO, Vesalio
[email protected]

SOURCE Vesalio