Two New Aspiration Devices Receive FDA Clearance for Peripheral and Neurovascular Thrombectomy

The Food and Drug Administration (FDA) has granted 510(k) clearance to 2 devices developed by Vesalio (Plano, TX) designed to be used for aspiration during thrombectomy in the peripheral or neurovascular arterial setting. Although the names of the devices were not detailed in a press release issued by the company, Vesalio stated that both products devices use microfiltration and Drop Zone (Vesalio, Plano, TX) technologies to efficiently remove clots.

“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.”

Source: Vesalio. Vesalio announces FDA clearance of two aspiration devices for peripheral and neurovascular applications. Press release. November 18, 2025.