BTG has announced that it has received 510k clearance from the US Food and Drug Administration for LC Bead Lumi, the first commercially available radiopaque embolic bead, for the embolization of hypervascular tumours and arteriovenous malformations.
LC Bead Lumi is a next generation development of LC Bead, the market leading embolic bead, that enables real-time visible confirmation of bead location during embolization. This has the potential to provide interventional radiologists increased control, enabling real-time adjustments to optimise patient treatment. The lasting radiopacity of LC Bead Lumi means they will also be visible in follow-up scans, allowing precise evaluation of the completeness of tumour treatment.
Louise Makin, BTG’s CEO, commented: “LC Bead Lumi reinforces our leadership in embolization technology and our focus on bringing to market innovative products that better serve specialist physicians and their patients. We look forward to securing regulatory clearances for additional radiopaque bead products in other markets.”