Nipro’s Avantec Vascular Gains FDA Clearance for Thrombectomy System

February 4, 2026—Avantec Vascular, a Nipro company, announced FDA 510(k) clearance of its thrombectomy system, which is intended for the treatment of thrombus in the peripheral venous system. Specifically, the indication includes removal of fresh soft emboli and thrombi from vessels of the peripheral venous system ≥ 7 mm in diameter.

According to Avantec, its new thrombectomy system uses both mechanical and aspiration methods of action to remove clot and emboli, combining a rotating tip with vacuum aspiration to remove a wide variety of blood clot.

“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,” commented Sirish Kishore, MD, in the press release. Dr. Kishore, Clinical Assistant Professor in the Department of Radiology at Stanford University in Stanford, California, continued, “Preclinical data are encouraging, and I look forward to the results of the upcoming clinical studies.”

The company anticipates an initial limited market launch in 2026 that will be followed by a wider commercial launch, noted the press release.