The US Food and Drug Administration (FDA) has cleared for marketing the Philips CavaClear Laser Sheath, the first laser-based device to facilitate removal of inferior vena cava (IVC) filters when other methods of removal fail.
“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, Office of Cardiovascular Devices, FDA Center for Devices and Radiological Health, said in a news release.
“[This] 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,” said Zuckerman.
IVC filters are frequently placed in patients at risk for pulmonary embolism when anticoagulant therapy is contraindicated or ineffective.
Although some IVC filters are left in place permanently, reports of adverse events associated with IVC filters led the FDA to advise that the devices be removed as soon as safely possible.
The Philips CavaClear Laser Sheath device facilitates detachment of adherent IVC filters from the IVC wall using ultraviolet laser energy to remove a small amount of the tissue.
The device is designed for use in conjunction with conventional snare devices to assist in IVC filter removal.
The FDA assessed the safety and effectiveness of the device through a retrospective, real-world evidence clinical study.
The study, which evaluated laser-assisted IVC filter removal in 265 patients at seven centers, demonstrated a procedural technical success rate of 96%.
There was a low (3%) rate of significant device-related complications, including IVC injury causing bleeding, hematoma formation, and filter breakage.
The FDA said the Philips CavaClear Laser Sheath device should not be used when a blood clot is present within the filter or surrounding veins, when the IVC filter is not accessible, or with filters that are not metal.
The device is not indicated to remove Bird’s Nest IVC filters and VenaTech IVC filters.
The Philips CavaClear Laser Sheath was granted breakthrough device designation and was reviewed through the de novo premarket review pathway, a regulatory pathway for low-to moderate-risk devices of a new type.