The US Food and Drug Administration (FDA) has formally approved the marketing of the Philips CavaClear Laser Sheath. This is the first laser-based device that can be used to remove inferior Vena cava filters (IVC) when other methods do not work.
“To date, there have been limited options for the successful removal of embedded IVC filters, as they are difficult to retrieve due to the potential risks 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.
Zuckerman stated that “[this] FDA action will provide physicians with a crucial tool for the safe removal IVC filters and could reduce the risk of complications for patients.”
IVC filters are frequently used in patients at risk for embolisms in the pulmonary system when anticoagulant therapy is ineffective or ineffective.
Although certain IVC filters are left in place permanently, reports of adverse events related to IVC filters prompted the FDA to recommend that the devices be removed as quickly as is safest.
The Philips CavaClear Laser sheath allows the removal of IVC filters that have been glued to the wall with ultraviolet laser energy. This is done to eliminate a small amount tissue.
This device can be used in conjunction with other snare devices in order to assist in IVC filter elimination.
FDA conducted a retrospective clinical study to determine the safety and effectiveness the device.
The study, which evaluated laser-assisted IVC filter removal in 265 patients at seven centers, showed a procedural technical success rate of 96%.
A small (3%) proportion of serious device-related complications were reported, including bleeding from the IVC as well as hematoma formation and filter breakage.
According to the FDA guidelines, the Philips CavaClear Laser Sheath is not recommended when a blood clot is formed within the filter or in the veins surrounding it. The FDA also advised that the IVC filter should not be accessible or that the filters aren’t made of metal.
The device is not designed to remove VenaTech IVC filters or Bird’s Nest IVC filter.
The Philips CavaClear Laser Sheath was granted breakthrough device designation and went by the de novo premarket review pathway an approval process for devices with moderate to low risk of a new type.
