
Guidance for Sponsors
Guidance for Sponsors · Volume 6, Issue 10 · 2026 Edition
Inferior Vena Cava Filters: Medical Imaging in Clinical Trials
By John Stoll, M.D.
Venous thromboembolism affects as many as 900,000 Americans each year and causes an estimated 60,000 to 100,000 deaths.[1] Anticoagulation is the treatment, but for patients who cannot be anticoagulated, an inferior vena cava (IVC) filter offers mechanical protection against pulmonary embolism. Filter use expanded dramatically with the introduction of retrievable devices, then came under scrutiny when the FDA warned of fractures, migration and perforation and when randomized evidence failed to show benefit in patients who could receive anticoagulation. Since then a large prospective trial has defined the safety of modern filters, professional societies have issued evidence-based guidelines and imaging has become central to both the indication for a filter and its follow-up. This issue reviews the evidence and the imaging a filter trial requires.
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