Philips earns FDA breakthrough status for IVC filter removal device

Royal Philips has been awarded a special designation for its new medical device that safely removes IVC filters during interventional procedures, the company announced Wednesday.

The Dutch health giant’s laser-assisted tool is designed to ablate tissue and help extract IVC filters that clinicians were previously unable to remove. The special U.S. Food and Drug Administration’s Breakthrough Device Designation is assigned to medical tools that have the potential to effectively treat life-threatening conditions.

“Breakthrough Device Designation reflects the potential impact that this technology could have on countless patients where this technology can be applied to safely retrieve filters by an expert physician, thereby reducing their risk of significant filter-related complications,” Kush R. Desai, MD, associate professor of radiology, surgery, and medicine, and director of deep venous interventions at Northwestern University, said in a statement.

IVC filters are used to treat venous thromboembolism and capture blood clots before they move to vital organs, such as the heart or lungs. But when filters break and travel to other parts of the body, physicians have no FDA-approved tools for extraction. And even with advanced options, failure rates for these interventional procedures are high. Two independent, prospective studies found this laser-assisted device was 96%-99% effective, with a major adverse event rate of 0.7%-2%. Health Imaging