Philips announced on Wednesday that it had received ‘de novo’ approval from the Food and Drug Administration (FDA) for its laser vena cava filter extraction device, CavaClear.
The Dutch manufacturer of healthcare equipment points out that this system thus becomes the first and only tool for extracting vena cava filters to be approved by the American health authority.
The FDA granted CavaClear breakthrough device status this summer, a qualification that speeds up the regulatory process for devices that improve patient care.
According to Philips, studies show that laser surgery is effective in over 99% of operations, with the key to very low complication rates.
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