The proposed device will help ablate tissue to remove an IVC filter when earlier methods of removal have failed
Health technology company Royal Philips has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its laser-assisted inferior vena cava (IVC) filter removal device.
The device has been designed for ablating tissue to remove an IVC filter when earlier methods of removal have failed.
IVC filters are generally used for the treatment of patients with venous thromboembolism, a condition of forming blood clots in the deep veins of the leg, groin or arm and can travel via the circulatory system.
The filters are placed in the inferior vena cava to prevent blood clots from moving to the heart or lungs.
According to the company, research has demonstrated that IVC filters may have long-term complications and may fracture and travel through the bloodstream to other parts of the body.
IVC filters may also result in long-term risks such as lower limb deep vein thrombosis and IVC occlusion.
Philip image-guided therapy chief medical officer and interventional radiologist Dr Atul Gupta said: “There is a clear need for an innovative device to help physicians more safely perform advanced IVC filter removal and I believe that the Philips excimer laser sheath may greatly enhance the options available to succeed in filter retrieval.
“Breakthrough Device Designation is an important step for a medical innovation such as this one to help fill an unmet need in patient care.”
In April this year, Philips secured 510(k) clearance from the FDA for its SmartCT image acquisition, visualisation and measurement software.