Philips’ CavaClear Laser-Assisted IVC Filter Removal Device Launched in the United States

April 21, 2022—Royal Philips announced that the first patients have been successfully treated for inferior vena cava (IVC) filter removal using the company’s CavaClear IVC filter removal laser sheath. The first two patients were successfully treated at Northwestern Medicine in Chicago, Illinois, by Kush R. Desai, MD, and at Stanford Hospital in Palo Alto, California, by William T. Kuo, MD.

In December 2021, Philips announced FDA de novo clearance for the CavaClear device for advanced IVC filter removal. The device is commercially available in the United States.

According to the company, CavaClear provides an effective, minimally invasive solution for embedded IVC filters to help physicians reduce risk of significant filter-related complications in patients and improve workflow performance. The device uses circumferential tissue ablation to aid in capturing the filter within seconds of laser activation, which can help increase procedural efficiency during removal and may help lower costs by reducing the number of retrieval attempts needed to remove an embedded filter. In addition, the device is designed for physicians to integrate into their workflow and reduce the need for high-force retrievals that could increase the chance of a complication.

Dr. Desai, who is Associate Professor of Radiology, Surgery, and Medicine, and Director of Deep Venous Interventions, Division of Interventional Radiology at Northwestern University Feinberg School of Medicine, treated a patient with CavaClear at Northwestern Medicine by removing an IVC filter that was placed more than 6 months before for deep vein thromboembolism.

The company noted that an attempt to retrieve the filter was made approximately 4 months postimplantation at another institution; however, the procedure was unsuccessful, and the patient was referred to Dr. Desai who used CavaClear to quickly and safely free the embedded filter from the caval wall, enabling the patient to be filter-free.

“Millions of patients have IVC filters that are no longer indicated, and CavaClear helps physicians experienced in IVC filter retrieval work towards the goal of safely removing such devices, in line with regulatory guidance,” commented Dr. Desai in the company’s press release.

At Stanford Hospital, Dr. Kuo performed a CavaClear retrieval on a chronically embedded IVC filter that was placed more than 16 years ago. The filter was rediscovered after the patient developed lifestyle-limiting pain and blood vessel occlusions related to the filter. Because of the complexity, none of the patient’s original physicians outside of the United States were able to provide a safe treatment plan; so, they referred the patient to the Stanford IVC Filter Clinic.

Dr. Kuo stated in Philips’ press release, “We chose to use CavaClear on a chronic filter implant that was embedded for over 16 years and completely encased in scar tissue. Prior to our discovery of the laser technique, pioneered at Stanford, percutaneous removal would have been impossible, but the use of CavaClear allowed us to achieve successful removal within minutes—highlighting the first ever use of CavaClear to remove a chronic filter implant. Although the device is now cleared in the United States, embedded IVC filters remain a worldwide problem.”