The FDA has cleared Philips to start producing and marketing its CavaClear Laser Sheath IVC filter removal system. The device is the first of its kind and was developed to aid in the removal of IVC filters when other attempts at removing the devices resulted in failure.
The removal, and failed removal, of IVC filters is a long-known issue in the medical community. The small, spider-like devices were developed to aid in the capture of blood clots and prevent them from making their way to the lungs or heart. A significantly high number of IVC filter failures, however, led to parts of the devices breaking off and making their way through the patient’s bloodstream. Associated damage from such an event included perforation of blood vessels and migration of the IVC filter into other areas of the patient’s body. In addition, some IVC filters were becoming embedded in the patient’s tissues. This could make the complete removal of the device nearly impossible without causing significant injury.
By 2014, enough IVC filter injury reports had been received that the FDA issued a safety communication on their use. While removal of the IVC filter was becoming increasingly less common, the communication advised doctors to schedule the removal of a patient’s IVC filter as soon as the threat of a blood clot had passed.
The CavaClear Laser Sheath uses lasers to remove small amounts of tissue that may keep an IVC filter lodged in place and the FDA appears to be excited by the possibilities of such a device. “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,” said the director of the FDA’s Office of Cardiovascular Devices. “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.”
Self-congratulatory tone aside for an agency that, by all accounts, deserves neither praise nor congratulations, the addition of a new device to help those suffering from the pain and dangers of IVC filter failure can only be seen as a good thing and a step forward in their care.
