The laser-based device is designed to remove tissue to facilitate detachment of an IVC filter during retrieval when earlier methods of removal have failed
Royal Philips has secured marketing authorisation from the US Food and Drug Administration (FDA) for its laser-based device to remove inferior vena cava (IVC) filters.
The new device, dubbed Philips CavaClear Laser Sheath, is designed for patients with an IVC filter implanted into the largest vein in the body. It is a small cage-like device that helps in capturing blood clots and obstructs them from traveling to the lungs.
According to the FDA, IVC filters are generally used for the treatment of patients who are at risk for pulmonary embolism when treatment with blood thinners cannot be used or not effective.
The laser-based device is designed to remove tissue to facilitate detachment of an IVC filter during retrieval when earlier methods of removal have not worked.
The FDA’s Centre for Devices and Radiological Health’s cardiovascular devices office director Dr Bram Zuckerman said: “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.”
Under the removal process, Philips CavaClear Laser Sheath device is used to detach firmly adherent IVC filters from the IVC wall using ultraviolet laser energy to remove a small amount of the tissue.
To assist in IVC filter removal, the device is also designed for use along with conventional snare devices.
Through a retrospective and real-world evidence clinical study, the FDA evaluated the safety and efficacy of the Philip’s device.
The trial, which assessed laser-assisted IVC filter removal in 265 patients at seven clinical sites, has shown a procedural technical success rate of 96%, stated FDA.
Earlier this month, Philips has secured 510(k) clearance from the FDA for its IntelliVue MX750 and IntelliVue MX850 acute patient monitors.