Sunnyvale, California – February 3, 2026 – Avantec Vascular, a NIPRO Company, has announced FDA 510(k) clearance for its new thrombectomy system, offering a breakthrough treatment for patients with thrombus in the peripheral venous system. This approval introduces a minimally invasive, AI-informed approach to managing venous thromboembolism (VTE), including deep vein thrombosis (DVT), one of the most prevalent vascular conditions worldwide.
More than 1 million people in the United States and 50 million globally suffer from VTE, making it the third most common vascular disease after heart attack and stroke. This thrombectomy system provides an advanced alternative to conventional surgical interventions, complementing anticoagulation therapy while improving patient outcomes and procedural efficiency.
Sirish Kishore, MD, Clinical Assistant Professor, Department of Radiology, Stanford University, and advisor to Avantec Vascular, said:
“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 in one device. Preclinical data are encouraging, and I look forward to the results of the upcoming clinical studies.”
The device is cleared under FDA 510(k) K251207, indicated for the removal of fresh soft emboli and thrombi from vessels of the peripheral venous system greater than 7 mm in diameter. By employing a minimally invasive, percutaneous approach, clinicians can mechanically disrupt, aspirate, and remove thrombus, improving blood flow and alleviating symptoms with greater precision and reduced recovery time.
The system combines mechanical maceration and vacuum aspiration via a novel rotating tip mechanism, enabling efficient removal of a broad spectrum of clot types. Key benefits include:
Versatility in treating multiple thrombus subtypes in a single session.
Reduced procedure time due to simultaneous aspiration and maceration.
Enhanced venous stabilization and improved blood flow, supporting better patient outcomes.
Timing and Market Impact
Avantec plans an initial limited market launch in 2026, targeting key physician partners across the United States, with broader commercialization to follow. The device addresses an estimated $0.8 billion U.S. market opportunity, reflecting significant potential to enhance clinical care for patients with venous thromboembolism.
