Health technology provider Royal Philips announced the FDA has granted De Novo Clearance for its Philips Inferior Vena Cava (IVC) Filter Removal Laser Sheath to remove an IVC filter when previous methods of removal have failed.
Earlier in 2021, the FDA granted the Philips CavaClear IVC Filter Removal Laser Sheath Breakthrough Device Designation. Laser technology has been clinically proven to provide a success rate over 99%, with low complication rates.
IVC filters are used to treat patients with venous thromboembolism, in which blood clots form in the deep veins of the leg and groin, and can travel through the circulatory system. They are placed in the inferior vena cava to capture blood clots from moving to the lungs. However, research has shown that IVC filters may have long-term complications.
The filters can fracture and travel through the bloodstream to other parts of the body. Other identified long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. The FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated.
“Today is a historic day. With the approval of CavaClear, physicians now have a device specifically geared remove chronically embedded IVC filters,” says Kush R. Desai MD, FSIR, associate professor of Radiology, Surgery, and Medicine, and Director of Deep Venous Interventions at Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. “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.”
Two independent and prospective clinical studies demonstrated that laser-assisted retrieval was 96-99.4 percent effective with a major adverse event rate of between 0.7 to 2 percent. Philips 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. In addition, the simple and safe design is easy for physicians to integrate into their workflow.
“With the FDA’s clearance of CavaClear more than one million patients and their physicians now have access to a safe, effective and efficient option for advanced IVC filter removal,” says Chris Landon, senior vice president and general manager Image Guided Therapy Devices at Philips. “This clearance demonstrates the commitment of Philips to innovating procedures with physician collaboration to meet unmet needs that can have a critical impact on the lives of patients and their families.”