![]() ![]() “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.” “With the FDA’s clearance of our IVC Filter Removal Laser Sheath – CavaClear – more than one million patients and their physicians now have access to a safe, effective and efficient option for advanced IVC filter removal,” said Chris Landon, Senior Vice President and General Manager Image Guided Therapy Devices at Philips. In addition, the simple and safe design is easy for physicians to integrate into their workflow. 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. Two independent and prospective clinical studies demonstrated that laser-assisted retrieval was 96-99.4% effective with a major adverse event rate of 0.7-2%. Physicians previously had very few tools to remove the filter when complications occurred and until now there were no FDA-approved devices for this type of advanced removal.Ĭlinical research supports laser-assisted removal Advanced retrieval tools and techniques are required if the IVC filter becomes embedded in the vasculature. įailure rates for IVC filter removal can be high and prior to CavaClear, limited options for removal existed if the filter became difficult to remove. The FDA recommends that implanting physicians consider removing retrievable IVC filters as soon as they are no longer indicated. Other identified long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. The filters can fracture and travel through the bloodstream to other parts of the body. However, research has shown that IVC filters may have long-term complications. They are placed in the inferior vena cava to capture blood clots from moving to the lungs. 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. Laser has been clinically proven to provide a success rate over 99%, with low complication rates. Earlier in 2021, the FDA granted the device Breakthrough Device Designation. CavaClear is the first and only FDA-cleared solution for advanced IVC filter removal. Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology today announced the FDA has granted De Novo Clearance for Philips IVC Filter Removal Laser Sheath – CavaClear – to remove an IVC filter when previous methods of removal have failed. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |