Philips CavaClear IVC Filter Removal Laser Sheath Receives FDA Clearance

December 22, 2021—Royal Philips announced that the FDA has granted de novo clearance for the Philips CavaClear inferior vena cava (IVC) filter removal laser sheath.

According to Philips, the CavaClear device is intended to remove an IVC filter when previous methods of removal have failed. In July 2021, the company announced that the FDA granted Breakthrough Device designation for the CavaClear.

Philips stated that CavaClear uses circumferential tissue ablation that can aid in capturing the filter within seconds of laser activation, which can help increase physician efficiency during removal, and may help lower costs by reducing the number of retrieval attempts needed to remove an embedded filter.

The device has been clinically proven to provide a success rate of more than 99% with low complication rates, noted the company. Two independent and prospective clinical studies demonstrated that laser-assisted retrieval was 96% to 99.4% effective with a major adverse event rate of 0.7% to 2.0%.

“Today is a historic day,” commented Kush R. Desai, MD, in Philips’ press release. “With the approval of CavaClear, physicians now have a device specifically geared remove chronically embedded IVC filters. Backed by evidence, this technology can be applied to retrieve IVC filters that are no longer indicated, reducing potential clinical risk for patients, and satisfying the FDA’s guidance to retrieve filters when they are no longer indicated.” Dr. Desai is Associate Professor of Radiology, Surgery, and Medicine, and Director of Deep Venous Interventions at Northwestern University Feinberg School of Medicine in Chicago, Illinois.