Cookie Consent by Free Privacy Policy website Philips receives FDA De Novo Clearance for Breakthrough Device Designation for IVC Filter Removal Laser Sheath – CavaClear
december 22, 2021 - Philips

Philips receives FDA De Novo Clearance for Breakthrough Device Designation for IVC Filter Removal Laser Sheath – CavaClear

  • Philips IVC Filter Removal Laser Sheath – CavaClear – is intended to safely ablate tissue to remove embedded IVC filters
  • CavaClear is a first-in-class FDA-cleared solution for advanced IVC filter removal
  • It is estimated that in the United States more than one million patients with IVC filters would benefit from filter removal to reduce the risk of long-term complications [1,2]
  • 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% [3,4]

Amsterdam, the NetherlandsRoyal 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. CavaClear is the first and only FDA-cleared solution for advanced IVC filter removal. Earlier in 2021, the FDA granted the device Breakthrough Device Designation. Laser has been clinically proven to provide a success rate over 99%, with low complication rates [3].

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 [5]. 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 [2].

Failure rates for IVC filter removal can be high and prior to CavaClear, limited options for removal existed if the filter became difficult to remove. Advanced retrieval tools and techniques are required if the IVC filter becomes embedded in the vasculature. 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.

“Today is a historic day. With the approval of CavaClear, physicians now have a device specifically geared remove chronically embedded IVC filters,” said 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.”

Further information in the press release to download