Nipro's Avantec Vascular Gains FDA Clearance for Thrombectomy System

The new device is intended to treat deep vein thrombosis by removing clots and emboli.

Feb. 4, 2026 at 6:23pm

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Avantec Vascular, a Nipro company, has announced that its thrombectomy system has received FDA 510(k) clearance for the treatment of deep vein thrombosis. The system uses both mechanical and aspiration methods to remove a wide variety of blood clots from vessels 7 mm or larger in diameter.

Why it matters

This new thrombectomy system could expand the range of venous thrombus subtypes that can be treated in a single session, combining aspiration and maceration functions in one device. This could provide a more effective solution for patients suffering from deep vein thrombosis.

The details

Avantec's thrombectomy system uses a rotating tip along with vacuum aspiration to remove clots and emboli. The company anticipates an initial limited market launch in 2026 followed by a wider commercial launch.

  • Avantec Vascular announced FDA 510(k) clearance on February 4, 2026.
  • The company plans an initial limited market launch in 2026 followed by a wider commercial launch.

The players

Avantec Vascular

A Nipro company that has developed a new thrombectomy system to treat deep vein thrombosis.

Sirish Kishore, MD

A Clinical Assistant Professor in the Department of Radiology at Stanford University who commented on the new thrombectomy system.

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What they’re saying

“This new thrombectomy system may expand the range of venous thrombus subtypes that can be treated in a single session by combining aspiration and maceration functions in one device with a favorable profile.”

— Sirish Kishore, MD, Clinical Assistant Professor, Department of Radiology, Stanford University

What’s next

The company anticipates an initial limited market launch of the thrombectomy system in 2026 that will be followed by a wider commercial launch.

The takeaway

Avantec Vascular's new FDA-cleared thrombectomy system could provide a more effective solution for treating deep vein thrombosis by combining aspiration and mechanical clot removal in a single device, potentially expanding the range of venous thrombus subtypes that can be treated.