The US Food and Drug Administration (FDA) has granted marketing authorisation to Philips’ Inferior Vena Cava (IVC) filter removal device, CavaClear Laser Sheath.
CavaClear is claimed to be the first laser-based device that can be used to remove IVC filters.
It is designed for patients with an IVC filter inserted to capture blood clots and prevent transmission to the lungs.
IVC filter is a small cage-like device which is frequently used in patients who are at pulmonary embolism risk when treatment with blood thinners is ineffective.
Although certain IVC filters are left permanently, the FDA issued a safety communication to remove the devices as quickly as blood clots are no longer at risk for the patient due to reports of adverse events related to IVC filters.
Using ultraviolet laser energy, Philips CavaClear laser sheath removes tissue to enable the detachment of IVC filters from the IVC wall to eliminate a small amount tissue.
It can be used in conjunction with other snare devices in order to assist in IVC filter removal.
The US FDA has evaluated the device’s efficacy and safety in a real-world evidence, retrospective clinical study.
In the study, the laser assisted IVC filter removal was evaluated in 265 participants at seven centres and showed 96% procedural technical success rate.
FDA Center for Devices and Radiological Health Cardiovascular Devices Office director Bram Zuckerman said: “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.
“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.”
The regulator stated that the Philips CavaClear Laser Sheath is not recommended when a blood clot is formed within the filter or in the veins surrounding.
It also noted that the device is not designed to remove VenaTech IVC filters and Bird’s Nest IVC filter.
In July this year, the US FDA granted breakthrough device designation to the laser assisted IVC filter removal device.