The FDA today announced the authorization of the first laser-based device for removing IVC filters, developed by Royal Philips (NYSE:PHG).
Authorization came through the de novo pathway, with Philips’ device receiving FDA breakthrough device designation for removing IVC (inferior vena cava) filters.
Philips designed the device for patients who have an IVC (inferior vena cava) filter inserted into the largest vein in the body to capture blood clots and prevent them from traveling to the lungs. The new device — Philips’ CavaClear laser sheath — removes tissue to facilitate the detachment of an IVC filter during retrieval when previous removal methods have failed.
The Amsterdam-based company designed the device to facilitate the detachment of the firmly adherent IVC filters from the IVC wall. It uses ultraviolet laser energy to remove a small amount of the tissue. It’s made for use in conjunction with conventional snare devices to assist in filter removal, according to an FDA news release.
FDA said it assessed the safety and effectiveness of the CavaClear device through a retrospective, real-world evidence clinical study of 265 patients across seven clinical sites. The study demonstrated a procedural, technical success rate of 96%, with a 3% rate of significant device-related complications, including IVC injury causing extravasation (bleeding), hematoma formation (bleeding outside of the blood vessel), and filter breakage.
“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,” Director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health Dr. Bram Zuckerman 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.”
Use of the Philips CavaClear Laser Sheath 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, FDA said. The device may not be used to remove Bird’s Nest IVC filters and VenaTech IVC filters.