FDA Clears BTG’s LC Bead Lumi
December 14, 2015—BTG plc announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the company’s LC Bead Lumi, a radiopaque embolic bead for embolization of hypervascular tumors and arteriovenous malformations. LC Bead Lumi is a next-generation version of BTG’s LC Bead embolic bead.
According to BTG, the LC Bead Lumi’s radiopacity technology enables real-time visible confirmation of bead location during embolization, providing interventional radiologists more control for precise evaluation of the completeness of tumor treatment and enhanced endpoint determination.
FDA clearance of the LC Bead Lumi was supported by comprehensive clinical evaluation reports on the safety and efficacy of LC Bead from more than 30 peer-reviewed clinical publications, noted the company.
In BTG’s press release, Bradford Wood, MD, commented, “Embolization procedures using precisely calibrated microspheres such as LC Bead have delivered real benefits for patients, but to date we’ve only been able to measure the accuracy of the treatment delivery based on response to the procedure. With this technological breakthrough, for the first time I can see where the beads are as I’m conducting the embolization procedure. This has the potential to offer a new level of precision and control and to allow me to make real-time adjustments to optimize how I treat the patient. I can see where it is going, and I can demonstrate to my patients that treatment has been placed exactly where it’s needed.” Dr. Wood is Director of the National Institutes of Health Center for Interventional Oncology and Chief of Interventional Radiology at the National Institutes of Health in Bethesda, Maryland.