August 02, 2016
BTG announces successful CE Mark reclassification for DC Bead® to Class III based on its ability to administer medicines
London, UK, 02 August 2016
BTG plc (LSE: BTG), a global specialist healthcare company, today announced that it has obtained European Conformity (CE) Mark from the Notified Body British Standards Institution (BSI) following completion of the reclassification of DC Bead® and DC BeadM1™ as Class III medical devices under Rule 8 of Annex IX to Directive 93/42/EEC.
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 BeadM1™ 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 BeadM1™. 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 BeadM1™ 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.
About BTG Interventional Medicine
BTG Interventional Medicine is part of BTG plc, a growing international specialist healthcare company. As medicine moves from major surgery to minor procedure, from the systemic to the local, no company endeavours to do more than BTG Interventional Medicine to help doctors in their quest to see more, reach further and treat smarter. Our growing portfolio of Interventional Medicine products is designed to advance the treatment of cancer tumours, advanced emphysema, severe blood clots, and varicose veins. To learn more about BTG Interventional Medicine, please visit: btg-im.com.
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 survival1-5. In metastatic colorectal cancer patients, DC Bead® has been shown to offer improved survival and enhanced quality of life versus systemic chemotherapy alone6. For instructions for use7 and important safety information, please visit: dcbead.com.
For further information contact:
Chris Sampson, Corporate Communications Director
+44 20 7575 1595; Mobile: +44 7773 251 178
+44 208 618 2752; Mobile: +44 7825 238 898
1. Lammer J et al. Cardiovasc Intervent Radiol 2010; 33: 41-52.
2. Song MJ et al. Eur J Gastroenterol Hepatol 2011; 23: 521-7.
3. Dhanasakeran R et al. J Surg Oncol 2010; 101: 476-80.
4. Burrel M et al. J Hepatol 2012; 56: 1330-5.
5. Malagari K et al. Cardiovasc Intervent Radiol 2012; 35: 1119-28.
6. Fiorentini G et al. Anticancer Res 2012; 32: 1387.
7. DC Bead™ / DC BeadM1™ Instructions for Use.