Laser-assisted IVC filter removal device earns FDA’s breakthrough device designation
Royal Philips has received the FDA’s breakthrough device designation for its new laser-assisted inferior vena cava (IVC) filter removal solution.
The device is intended to help implanting physicians remove IVC filters as long as they are no longer needed. These filters are associated with certain long-term risks if not properly removed in time, Philips emphasized in its announcement.
The FDA’s decision was based in part on two independent clinical studies. Both were published in the Journal of the American Heart Association—one in August 2020, the other in November 2020.
"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,” interventional radiologist Atul Gupta, MD, chief medical officer of image-guided therapy for Philips, said in a statement. “Breakthrough device designation is an important step for a medical innovation such as this one to help fill an unmet need in patient care.”
“Laser-assisted filter retrieval may be a critical tool for the safe retrieval of filters with extended implantation times,” added Kush R Desai, MD, an associate professor at Northwestern University Feinberg School of Medicine in Chicago and a researcher with experience using the device. “Breakthrough Device Designation reflects the potential impact that this technology could have on countless patients where this technology can be applied to safely retrieve filters by an expert physician, thereby reducing their risk of significant filter-related complications.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.