Vesalio Announces FDA 510(k) Clearance of pVasc NET, a Next-Generation Peripheral Mechanical Thrombectomy Device with Integrated Distal Filter

Vesalio Announces FDA 510(k) Clearance of pVasc NET, a Next-Generation Peripheral Mechanical Thrombectomy Device with Integrated Distal Filter

PR Newswire

DALLAS, Aug. 13, 2026

New device expands Vesalio's pVasc platform with integrated clot-capture technology designed to retain clot fragments during retrieval.

DALLAS, Aug. 13, 2026 /PRNewswire/ -- Vesalio, a global leader in vascular intervention, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for pVasc NET, a next-generation peripheral mechanical thrombectomy device featuring an integrated distal filter. The clearance expands Vesalio's pVasc® product portfolio and further advances the company's technology platform for the treatment of thromboembolic disease in the peripheral vasculature.

pVasc NET builds on the established pVasc platform, a self-expanding nitinol device delivered through a low-profile delivery catheter and designed for the non-surgical removal of emboli and thrombi from peripheral blood vessels.

The new pVasc NET design incorporates a fine-pore, dual-layer filter within the distal portion of the thrombectomy device. The integrated filter is designed to capture and retain clot fragments during clot retrieval while preserving the core features of Vesalio's proprietary Drop Zone™ architecture. The platform is designed to address a broad range of clot morphologies and provides radiopaque visualization as well as an aspiration-compatible workflow.

"Peripheral thrombectomy can be particularly challenging in small or diseased vessels, where maintaining control and preserving available runoff are important considerations," said Gustavo Prado, Ph.D., Vice President of Development and Regulatory at Vesalio. "pVasc NET builds on the proven design principles of our Drop Zone platform by incorporating an integrated filter designed to retain clot fragments during retrieval, while maintaining the low-profile delivery system and straightforward workflow physicians value."

"This FDA clearance represents an important expansion of our peripheral vascular portfolio and brings a differentiated technology to physicians treating thromboembolic disease across challenging anatomy," said Steve Rybka, Chief Executive Officer of Vesalio. "We believe pVasc NET will provide physicians with an important new tool for peripheral thrombectomy."

About Vesalio

Vesalio is a privately held medical device company focused on advancing the treatment of thromboembolic vascular disease through innovative technologies designed to improve patient care and clinical outcomes. Vesalio's proprietary NeVa®, enVast™, and pVasc® platforms are designed to remove a broad range of clot types and restore blood flow to compromised ischemic tissue in the brain, heart, and peripheral vasculature.

Vesalio products have been used to treat more than 20,000 patients in more than 60 countries. For more information, visit www.vesalio.com.

Investor Contacts
Steve Rybka, CEO, Vesalio
srybka@vesalio.com

J.D. McCulloch, CFO, Vesalio
jdmcculloch@vesalio.com

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SOURCE Vesalio