Royal Philips’ Laser-Assisted IVC Filter Removal Device Receives FDA Breakthrough Device Designation

July 21, 2021—Royal Philips announced that the FDA has granted Breakthrough Device designation for a laser-assisted inferior vena cava (IVC) filter removal device. The proposed device is intended for ablating tissue to remove an IVC filter when previous methods of removal have failed.

According to the company, the failure rate for IVC filter removal is high and limited options for removal exist if the filter has become difficult to remove. Advanced retrieval tools and techniques are required if the IVC filter becomes embedded in the vasculature. However, physicians have very few tools to remove the filter when this happens and there are no FDA-approved devices for this type of advanced removal.

Philips noted that recent research supports laser-assisted removal with two independent and prospective clinical studies published in the Journal of the American Heart Association (JAHA) demonstrating that laser-assisted retrieval was 96% to 99% effective with a major adverse event rate of 0.7% to 2%: William T. Kuo, MD, et al in JAHA (2020;9:e017916); and Kush R. Desai, MD, et al in JAHA (2020;9:e017240).

“Laser-assisted filter retrieval may be a critical tool for the safe retrieval of filters with extended implantation times,” commented Dr. Desai in the company’s announcement. “Breakthrough Device designation reflects the potential impact that this technology could have on countless patients where this technology can be applied to safely retrieve filters by an expert physician, thereby reducing their risk of significant filter-related complications.” 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.

Philips noted that FDA Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices program is to provide patients and health care providers with timely access to breakthrough medical devices. Under the program, the FDA will provide Philips with priority review and interactive communication regarding device development throughout the submission process, stated the company.