December 14, 2015
BTG announces FDA clearance for LC Bead LUMI™, the first commercially available radiopaque embolic bead in the US
London, UK, 14 December 2015
Unique LC Bead LUMI™ provides real-time visible confirmation of bead location during embolisation of hypervascular tumours and arteriovenous malformations
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 embolisation of hypervascular tumours and arteriovenous malformations (AVMs).
LC Bead LUMI™ is a next generation development of LC Bead®, the market leading embolic bead.
By enabling visualisation of beads during an embolisation 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 embolisation. LC Bead LUMI™ has the potential to offer interventional radiologists more control, allowing precise evaluation of the completeness of tumour treatment and enhanced end-point determination.
“Embolisation 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 embolisation procedure. This has the potential to offer a new level of precision and control, and to allow me to make real-time adjustments to optimise 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 embolisation 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.”
About BTG Interventional Medicine
BTG Interventional Medicine is part of BTG plc, a growing international specialist healthcare company. As medicine moves from major surgery to minor procedure, from the systemic to the local, no company endeavours to do more than BTG Interventional Medicine to help doctors in their quest to see more, reach further and treat smarter. Our growing portfolio of Interventional Medicine products is designed to advance the treatment of liver tumours, advanced emphysema, severe blood clots, and varicose veins. To learn more about BTG Interventional Medicine, please visit: btg-im.com.
About LC Bead LUMI™
LC Bead LUMI™ is the first commercially available radiopaque embolic bead cleared by the US Food & Drug Administration (FDA) for the embolisation of hypervascular tumours and arteriovenous malformations (AVMs).
LC Bead LUMI™ provides visible confirmation of bead location during AVM procedure. The lasting radiopacity of LC Bead LUMI™ means they will also be visible in follow-up scans. For instructions for use and important safety information, please visit: LCBeadLUMI.com
NIH does not endorse or recommend any commercial products, processes, or services. The views and opinions of authors expressed here do not necessarily state or reflect those of the US Government or the NIH, and they may not be used for advertising or product endorsement purposes.
For further information contact:
Chris Sampson, Corporate Communications Director
+44 20 7575 1595; Mobile: +44 7773 251 178
+44 208 618 2752; Mobile: +44 7825 238 898
Media Liaison – US
+1 202 828 5073; Mobile: +1 202 577 5847