Philips has scored a de novo clearance from the FDA for the first laser-based device for removing blood vessel filter implants that aim to strain out traveling blood clots before they damage the lungs or other organs.
Placed in the inferior vena cava, the largest vein in the body, these cage-like filters may have long-term complications—including the blocking of blood flow and device fractures—and the FDA recommends that they be removed after the dangers of venous thromboembolism have passed.
Philips’ CavaClear device is designed to be used where other retrieval methods have failed, including times when the filters have become lodged in a blood vessel.
“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, director of the FDA’s Office of Cardiovascular Devices, said in a statement.
The CavaClear catheter sheath uses ultraviolet laser light to remove small amounts of tissue from around the edges of a stubborn filter, which is then pulled out using conventional, snare-like devices.
Earlier this year, the sheath received a breakthrough designation from the agency, with the laser demonstrating a success rate of about 96% in clinical trials.
“With the FDA’s clearance of CavaClear more than 1 million patients and their physicians now have access to a safe, effective and efficient option for advanced IVC filter removal,” said Chris Landon, Philips’ general manager for image-guided therapy devices.
The agency reviewed the device’s safety and effectiveness in a study based on real-world evidence, showing a 3% rate of major complications such as bleeding or breakage of the filter itself.
The laser is not to be used with nonmetal filters, or with Cook Medical’s Bird’s Nest or B. Braun’s VenaTech filters, with the latter designed as a permanent implant.