BTG plc (LSE: BTG), a global specialist healthcare company, today announced it has received 510k clearance from the US Food and Drug Administration (FDA) for LC Bead LUMI™, the first commercially available radiopaque embolic bead for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). LC Bead LUMI™ is a next generation development of LC Bead®, the market leading embolic bead.
By enabling visualization of beads during an embolization procedure, LC Bead LUMI™ will help this technology achieve its full potential. LC Bead LUMI™ has been developed with revolutionary radiopacity technology that enables real-time visible confirmation of bead location during embolization. LC Bead LUMI™ has the potential to offer interventional radiologists more control, allowing precise evaluation of the completeness of tumor treatment and enhanced end-point determination.
"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," said Bradford Wood, M.D., Director of the NIH Center for Interventional Oncology and Chief of Interventional Radiology, "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."
LC Bead LUMI™ clearance was supported by comprehensive clinical evaluation reports on the safety and efficacy of LC Bead® from over 30 peer-reviewed clinical publications.
"BTG is focused on bringing to market innovative products in specialist areas of medicine to better serve doctors and, ultimately, do what's right for patients," said Sean Willis, BTG Technical Director. "It was this commitment and focus, and belief in the power of interventional medicine, which led our team of expert scientists and engineers to develop LC Bead LUMI™. For the first time, doctors will be able to see rather than assume the location of the beads, so they can see more and treat smarter."
"LC Bead LUMI™ reinforces BTG's leadership in embolization technology and we look forward to clearances for additional radiopaque bead products worldwide," commented Ken Pugh, BTG Vice President, Commercial Development and Interventional Oncology Marketing, the Americas. "We are excited about the possibilities that our new product offers. It's a new standard of care which would have seemed like science fiction only a generation ago. What we achieve with LC Bead LUMI™ can only be done in partnership with interventional radiologists and multidisciplinary teams. With that, we will work passionately to communicate the power of our product to improve human health."
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