The assessment takes account of the characteristics of DC Bead® and DC BeadM1TM with regards to their ability to administer medicines and the product-specific non-clinical and clinical data supporting the safe and effective conditions for use of DC Bead® in the approved clinical setting.
The conformity assessment procedure has resulted in clear indication statements to permit use of DC Bead® and DC BeadM1TM as Class III medical devices in transarterial chemoembolisation for the treatment of liver tumours, and specifically state:
DC Bead® and DC BeadM1™ are primarily intended as an embolic agent for the local treatment of malignant hypervascularised tumour(s) in the liver.
DC Bead® and DC BeadM1™ are compatible with doxorubicin for the local treatment of tumours in patients with hepatocellular carcinoma (HCC). Doxorubicin can be loaded prior to embolisation and as a secondary action, will elute a local, controlled and sustained dose to the tumour after embolisation.
DC Bead® and DC BeadM1™ are also intended to embolise the vessels supplying malignant colorectal cancer metastasised to the liver (mCRC).
DC Bead® and DC BeadM1™ are compatible with irinotecan which can be loaded prior to embolisation and then as a secondary action, elute a local, controlled and sustained dose to the liver metastases from colorectal cancer after embolisation.
"We are delighted to receive the Class III CE Mark approval for DC Bead® and DC BeadM1TM . Their ability to administer medicines in a controlled and sustained manner after chemoembolisation is widely documented and their clinical use and patient benefits are supported by extensive product-specific clinical data generated by BTG and the healthcare professionals we support" commented Russell Hagan, BTG Chief Technology Officer, Interventional Oncology.
"No company strives to do more than BTG to ensure the highest quality data underpins our products to properly inform the benefit-risk balance. The successful Class III CE Mark reclassification provides healthcare professionals with further confidence that DC Bead® and DC BeadM1™ are safe and effective."
DC Bead® and DC BeadM1TM are embolic drug-eluting beads capable of loading and releasing compatible chemotherapeutic agents. They are manufactured using a unique, patent-protected polymer and supported by a clinical data package comprising safety and clinical performance data in over 3,000 hepatocellular carcinoma (HCC) patients and over 600 patients with liver metastases from colorectal cancer.
DC Bead® is the only drug-eluting bead with CE Mark approval for loading with doxorubicin and irinotecan, providing an effective standardised liver-directed therapy for primary and metastatic liver cancer.
With ten years' clinical experience, extensive peer-review evidence supports the benefits offered by the unique chemistry of DC Bead®. In intermediate HCC, these benefits include improved tolerability and tumour response versus cTACE and high rates of five-year survival.1-
