An industry first: FDA authorizes marketing of laser-assisted IVC filter removal device
The FDA has authorized marketing of the first laser-based device for removing inferior vena cava (IVC) filters.
The device in question, the Philips CavaClear Laser Sheath, was designed to help clinicians detach IVC filters during the retrieval process. It earned the agency’s breakthrough device designation back in July.
“To date, there have been limited options for the successful removal of chronically embedded IVC filters, as they can be difficult to retrieve due to potential complications associated with the complex procedure,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. “Today’s action by the FDA will provide physicians with an important tool for the safe removal of IVC filters and potentially help reduce complications for patients. It also demonstrates FDA’s commitment to leveraging real world evidence where appropriate to evaluate device safety and effectiveness.”
While some IVC filters can be left in place permanently, the FDA has received reports of adverse events due to leaving them in too long. The agency officially recommends removing IVC filters once blood clots are no longer pose a threat to the patient’s health.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.