BTG's DC Bead Lumi Receives CE Mark Certification
March 13, 2017—BTG plc announced that it has received Class III CE Mark certification for European commercialization of the company's next-generation DC Bead Lumi. The device is a radiopaque drug-eluting bead that can be loaded with doxorubicin or irinotecan for the local treatment of tumors in patients with hepatocellular carcinoma and malignant colorectal cancer metastasized to the liver. The DC Bead Lumi provides real-time visible and lasting confirmation of bead location to control transarterial chemoembolization (TACE) procedures.
According to the company, the visibility of DC Bead Lumi during and after embolization allows physicians to individualize a patient’s treatment by enabling real-time evaluation of the completeness of tumor treatment and enhanced endpoint determination. DC Bead Lumi includes a tri-iodobenzyl moiety, which provides long-term radiopacity and facilitates future treatment decisions, because DC Bead Lumi is still visible in follow-up scans to identify areas of treatment and undertreatment.
In BTG's announcement, Tobias Jakobs, MD, commented "The ability to see bead location during TACE procedures is a key step in enhancing the quality and potentially minimizing complications of the procedure and can help improve treatment outcomes compared to current techniques. More importantly, the lasting radiopacity of DC Bead Lumi means I can show patients that treatment has been placed exactly where it’s needed.” Dr. Jakobs is from The Hospital of the Order of St. John of God in Munich, Germany.