Royal Philips (NYSE:PHG) announced today that the first patients were successfully treated with its CavaClear IVC filter removal laser sheath.
Patients were treated for inferior vena cava (IVC) filter removal using CavaClear at Northwestern Medicine (Chicago) by Dr. Kush R. Desai and at Stanford Hospital (Palo Alto, California) by Dr. William T. Kuo.
Amsterdam-based Philips designed CavaClear for patients who have an IVC (inferior vena cava) filter inserted into the largest vein in the body to capture blood clots and prevent them from traveling to the lungs. The new device — first laser-based device for removing IVC filters — removes tissue to facilitate the detachment of an IVC filter during retrieval when previous removal methods have failed.
Philips garnered FDA authorization for CavaClear in December 2021 through the de novo pathway, with the device receiving FDA breakthrough device designation.
Desai said in a news release that millions of patients have IVC filters that are no longer indicated, so CavaClear offers physicians a way to safely remove the devices in line with regulatory guidance. Desai treated the first patient, who had an attempt to retrieve their filter fail at four months post-implant before being referred to Desai, who successfully used CavaClear to remove the filter at more six months after implant.
Kuo performed the retrieval on a chronically embedded IVC filter placed more than 16 years ago. Due to case complexity, the patient’s original physicians outside the U.S. offered a safe treatment plan and referred the patient to Stanford.
“We are deeply moved to see Philips IVC filter removal laser sheath – CavaClear – have a positive impact on the lives of patients, and the ability to provide physicians with access to a safe, effective and efficient option for advanced IVC filter removal,” Philips CMO for Image-Guided Therapy Dr. Atul Gupta said in the release. “These are just the first of many successful cases to come, and a testament of the Philips commitment to innovating procedures and solutions with physician collaboration to improve patient outcomes.”