- For Immediate Release:
Today, the U.S. Food and Drug Administration authorized marketing of the first laser-based device for the removal of Inferior Vena Cava (IVC) filters. The device is designed for patients who have an IVC filter, a small cage-like device inserted into the largest vein in the body to capture blood clots and prevent them from traveling to the lungs. The new device, called the Philips CavaClear Laser Sheath, is intended for the removal of tissue to facilitate detachment of an IVC filter during retrieval when previous methods of removal have failed.
“To date, there have been limited options for the successful removal of chronically embedded IVC filters, as they can be difficult to retrieve due to potential complications associated with the complex procedure,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “Today’s action by the FDA will provide physicians with an important tool for the safe removal of IVC filters and potentially help reduce complications for patients. It also demonstrates FDA’s commitment to leveraging real world evidence where appropriate to evaluate device safety and effectiveness.”
IVC filters are commonly used to treat patients who are at risk for pulmonary embolism (a blood clot in the lungs) when treatment with blood thinners cannot be used or is ineffective. While some IVC filters are left in place permanently, the FDA issued a safety communication in 2014 based on reports of adverse events associated with IVC filters and recommended that implanting physicians consider removing the filter as soon as blood clots are no longer a risk for the patient.
During removal, the Philips CavaClear 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. The device is designed for use in conjunction with conventional snare devices to assist in IVC filter removal.
The FDA assessed the safety and effectiveness of the device through a retrospective, real-world evidence clinical study. The study, which evaluated laser-assisted IVC filter removal in 265 patients at seven clinical sites, demonstrated a procedural technical success rate of 96%. The study had a 3% rate of significant device-related complications, including IVC injury causing extravasation (bleeding), hematoma formation (bleeding outside of the blood vessel), and filter breakage.
Use of the Philips CavaClear Laser Sheath 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 nonmetal. The device may not be used in removal of Bird’s Nest IVC filters and VenaTech IVC filters.
The Philips CavaClear Laser Sheath was granted a Breakthrough Device Designation for the removal of IVC filters. The Breakthrough Devices Program is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions and that otherwise meet the statutory criteria for Breakthrough Device Designation.
The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no legally marketed predicate device to which the device can claim substantial equivalence.
The FDA granted the marketing authorization to Philips.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: U.S. Food and Drug Administration (FDA.gov)