Vesalio Earns FDA OK for pVasc Net Mechanical Thrombectomy Device

Vascular intervention company Vesalio has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for pVasc Net, a next-gen peripheral mechanical thrombectomy device that features an integrated distal filler.

pVasc Net build on the company’s pVasc platform, a self-expanding nitinol device delivered through a low-profile catheter. It’s designed for non-surgical removal of emboli and thrombi from peripheral blood vessels.

The technology boasts a fine-pore, dual-layer distal filter designed to capture clot fragments during retrieval while retaining Vesalio’s Drop Zone architecture. The platform supports various clot morphologies, radiopaque visualization, and aspiration-compatible workflows.

In December, the company earned FDA clearance for the enVast clot retriever. enVast was marketed as the first, only clot retriever specifically cleared for mechanical thrombectomy in the cardiac circulation.

Comments from Vesalio execs

Gustavo Prado, Ph.D. VP of development and regulatory: “Peripheral thrombectomy can be particularly challenging in small or diseased vessels, where maintaining control and preserving available runoff are important considerations. 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.”

Steve Rybka, CEO: “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. We believe pVasc NET will provide physicians with an important new tool for peripheral thrombectomy.”