Devices

Philips CavaClear Sheath Authorized

FDA has authorized marketing of the Philips CavaClear Laser Sheath, the first laser-based device for removing inferior vena cava (IVC) filters. An agency statement says the device is intended for removing tissue to facilitate detachment of an IVC filter during retrieval when previous methods of removal have failed.

The agency says the Laser Sheath device is designed to facilitate detachment of firmly adherent IVC filters from the IVC wall using ultraviolet laser energy to remove a small amount of the tissue. It is designed to be used in conjunction with conventional snare devices to assist in IVC filter removal.

The agency says it assessed the device’s safety and effectiveness through a retrospective, real-world evidence clinical study that evaluated laser-assisted IVC filter removal in 265 patients at seven clinical sites. The study demonstrated a procedural technical success rate of 96%, it says, with a 3% rate of significant device-related complications, including IVC injury causing bleeding, hematoma formation, and filter breakage.

Using the device is contraindicated when a blood clot is present within the filter or surrounding veins, when the IVC filter is not accessible, or when the filter is not metal.

The Laser Sheath was granted a breakthrough device designation for the removal of IVC filters. It was reviewed through the De Novo premarket review pathway.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome