FDA Clears Vesalio's pVasc NET, a Peripheral Clot-Removal Device With a Built-In Filter
The Special 510(k) adds a fine-pore filter to Vesalio's nitinol pVasc device to hold clot fragments during retrieval.
The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.
Key points
- The FDA found Vesalio's pVasc Net Mechanical Thrombectomy Device, submission K254211, substantially equivalent on August 5, 2026; Vesalio announced it on August 13.
- The company says the device adds a fine-pore, dual-layer distal filter designed to capture clot fragments during removal from peripheral vessels.
- Vesalio did not release clinical data, pricing or a launch date with the announcement.
Vesalio said on August 13 that the US Food and Drug Administration has cleared pVasc NET, a peripheral mechanical thrombectomy device that adds a built-in filter to catch clot fragments while a clot is being pulled out of a blood vessel, according to the company's release distributed by PR Newswire.
The FDA's 510(k) database lists submission K254211 for the pVasc Net Mechanical Thrombectomy Device from Vesalio, Inc., of San Diego. The agency received the submission, a Special 510(k), on December 29, 2025, and issued a decision of substantially equivalent on August 5, 2026. It was reviewed by the cardiovascular panel. A Special 510(k) is used for certain changes to a manufacturer's own already-cleared device.
Mechanical thrombectomy devices remove clots, known as thrombi and emboli, from blood vessels without open surgery. Vesalio said the new device builds on its existing pVasc platform, a self-expanding nitinol device delivered through a low-profile catheter and designed for the non-surgical removal of emboli and thrombi from peripheral blood vessels.
A filter inside the device
The change in pVasc NET is a fine-pore, dual-layer filter in the distal portion of the device, the company said. Vesalio said the filter is designed to capture and retain clot fragments during retrieval while keeping the core features of its Drop Zone architecture, the company's name for the design of its clot-retrieval devices. The company also said the platform is designed for a broad range of clot types, is visible under X-ray and works with aspiration, the use of suction alongside the device. Endovascular Today summarized the clearance on the same day.
"Peripheral thrombectomy can be particularly challenging in small or diseased vessels, where maintaining control and preserving available runoff are important considerations," said Gustavo Prado, Vesalio's vice president of development and regulatory. "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."
Company context
Steve Rybka, Vesalio's chief executive, called the clearance "an important expansion of our peripheral vascular portfolio" in the release. "We believe pVasc NET will provide physicians with an important new tool for peripheral thrombectomy," he said.
Vesalio is privately held. Besides pVasc, it markets the NeVa and enVast clot-removal platforms for vessels in the brain and heart, and the company said its products have been used to treat more than 20,000 patients in more than 60 countries. The release did not include clinical data for pVasc NET, pricing or a launch date.
Sources
- Vesalio Announces FDA 510(k) Clearance of pVasc NET, a Next-Generation Peripheral Mechanical Thrombectomy Device with Integrated Distal Filter, Vesalio (PR Newswire), August 13, 2026
- Vesalio's pVasc Net Mechanical Thrombectomy Device Receives FDA 510(k) Clearance, Endovascular Today, August 13, 2026
- 510(k) Premarket Notification K254211: pVasc Net Mechanical Thrombectomy Device, US Food and Drug Administration, August 5, 2026