BTG has announced that it has obtained CE mark from the Notified Body British Standards Institution (BSI) following completion of the reclassification of DC Bead and DC Bead M1 as class III medical devices.
The assessment takes account of the characteristics of DC Bead and DC BeadM1 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 Bead M1 as class III medical devices in transarterial chemoembolization for the treatment of liver tumours, and specifically state: DC Bead and DC Bead M1 are primarily intended as an embolic agent for the local treatment of malignant hypervascularised tumour(s) in the liver.
DC Bead and DC Bead M1 are compatible with doxorubicin for the local treatment of tumours in patients with hepatocellular carcinoma. Doxorubicin can be loaded prior to embolization and as a secondary action, will elute a local, controlled and sustained dose to the tumour after embolization.
DC Bead and DC Bead M1 are also intended to embolize the vessels supplying malignant colorectal cancer metastasised to the liver.
DC Bead and DC Bead M1 are compatible with irinotecan which can be loaded prior to embolization and then as a secondary action, elute a local, controlled and sustained dose to the liver metastases from colorectal cancer after embolization.
“We are delighted to receive the class III CE mark approval for DC Bead and DC Bead M1. Their ability to administer medicines in a controlled and sustained manner after chemoembolization 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.
DC Bead and DC Bead M1 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 patients and over 600 patients with liver metastases from colorectal cancer.