BTG (LON:BTG) said today that it won CE Mark clearance in the European Union for its DC Bead Lumi radiopaque drug-eluting bead. The bead is designed to be loaded with doxorubicin or irinotecan to locally treat tumors in patients with hepatocellular carcinoma and malignant colorectal cancer metastasised to the liver.
The company’s DC Bead Lumi also features real-time visible confirmation of the bead’s location, which the company claims will enhance control in transarterial chemoembolisation procedures.
The bead, which can be seen during and after embolisation, enables doctors to individualize a patient’s treatment and evaluate the completeness of tumor treatment, according to BTG.
“The ability to see bead location during TACE procedures is a key step in enhancing the quality and potentially minimising complications of the procedure, and can help improve treatment outcomes compared to current techniques,” Dr. Tobias Jakobs, from the Hospital of the Order of St. John of God in Germany, said in prepared remarks. “More importantly, the lasting radiopacity of DC Bead Lumi means I can show patients that treatment has been placed exactly where it’s needed.”
BTG also incorporated long-term radiopacity into the design of the drug-eluting bead, which makes the bead visible in follow-up scans to help identify areas of treatment and undertreatment.
“The Class III CE Mark approval for DC Bead Lumi is a real milestone and reinforces BTG’s leadership in embolisation technology, following on closely from our recent Class III CE Mark approval for DC Bead and DC BeadM1,” BTG head of interventional oncology Duncan Kennedy added. “DC Bead Lumi, the first ever radiopaque DEB, brings a new level of control enabling doctors to see rather than assume the location of the beads, providing the ability to adjust and optimise the embolisation procedure as they go. DC Bead Lumi is the next step in our ongoing commitment to transform cancer care with smarter solutions.”
