Laser-based IVC filter removal device gains marketing authorization from FDA
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The FDA announced it has authorized marketing of the first laser-based device for the removal of inferior vena cava filters.
IVC filters are used to treat patients at risk for pulmonary embolism when blood thinners either cannot be used or prove ineffective.
According to an FDA press release, the device (CavaClear Laser Sheath, Philips) is designed to uses ultraviolet laser energy to detach firmly adherent IVC filters from the IVC by removing a small amount of the tissue and intended for use in conjunction with conventional snare devices.
The device is designed for patients with an IVC filter and intended for the removal of tissue to facilitate detachment of an IVC filter during retrieval when previous retrieval attempts have failed.
The IVC removal device had previously received breakthrough designation from the FDA in July 2021.
“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 the release. “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.”
According to the release, the FDA issued a safety communication in 2014 based on reports of adverse events associated with IVC filters and recommended that implanting physicians consider removing the IVC filter as soon as blood clots are no longer a risk.
The device is contraindicated when a blood clot is present within the filter or surrounding veins, when the IVC filter is not accessible or when the filter is nonmetal, and the device may not be used for the removal of Bird’s Nest or VenaTech IVC filters, according to the release.
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