Royal Philips’ CavaClear laser sheath is a first-in-class laser-based device used for the removal of advanced inferior vena cava (IVC) filter, a small cage-like device that is implanted into the body’s largest vein to trap blood clots and prevent them from reaching the lungs.
CavaClear is a new device designed to ablate tissue safely, facilitating the removal of implanted IVC filters during retrieval when other removal techniques fail. It is intended to be used in conjunction with standard snare devices to support IVC filter removal.
The device received De Novo Clearance from the US Food and Drug Administration (FDA) in December 2021 after securing the breakthrough device designation in July 2021.
Royal Philips’ CavaClear laser sheath details
The CavaClear laser sheath device employs ultraviolet laser radiation to remove a small amount of tissue, facilitating the separation of strongly adhered IVC filters from the IVC wall during its removal.
The device uses circumferential tissue ablation, which can help in capturing the filter within seconds after laser activation. It can support physicians in improving their efficiency during removal and may reduce expenses by minimising the counts of retrieval efforts required to remove an embedded filter. The simple and safe design of the device offers a convenient option for physicians to include it in their workflow.
The use of the Philips CavaClear laser sheath device is contraindicated if a blood clot is present inside the filter or in adjacent veins when the IVC filter is inaccessible or it’s a nonmetal. The device cannot be used to remove Bird’s Nest or VenaTech IVC filters.
Inferior vena cava (IVC) filters
IVC filters are used for the treatment of patients with venous thromboembolism, a condition in which blood clots develop in the deep veins of the leg and groin and can spread through the circulatory system.
A study has indicated that IVC filters can have long-term complications. Long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. The filters can fracture and migrate through the blood circulation to other regions of the body.
More than one million people with IVC filters in the US are estimated to benefit from the CavaClear laser-assisted removal device to alleviate the risk of long-term complications.
Clinical studies supporting laser-assisted removal
A retrospective, real-world evidence clinical study evaluated the safety and effectiveness of the CavaClear laser sheath.
The study examined laser-assisted IVC filter removal in 265 patients across seven clinical locations and showed a 96% procedural technical success rate.
The study reported a 3% risk of severe device-related complications, including IVC damage, resulting in extravasation or bleeding, hematoma development or bleeding outside of the blood artery, and filter rupture.
The laser-assisted retrieval showed 96% to 99.4% effectiveness with a 0.7% to 2% probability of significant adverse events in two independent and prospective clinical trials.
Marketing commentary on Royal Philips
Founded in 1891, Royal Philips is a health technology company headquartered in Eindhoven, Netherlands.
Royal Philips received FDA 510(k) approval for its IntelliVue MX750 and IntelliVue MX850 acute patient monitors in December 2021.
The company provides innovative solutions integrating systems, smart devices, informatics and services, and leverages big data to assist its customers in achieving better health outcomes, improved patient and staff experiences, and lower cost of care, while enabling them to take better care of their health at every stage of life. Royal Philips employs 80,000 people in more than 100 countries.