BTG Announces CE Mark Certification for DC Bead LUMI™, the First Commercially Available Radiopaque Drug-Eluting Bead in the EU

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BTG Plc

07 Mar, 2017, 07:00 GMT

LONDON, March 7, 2017 /PRNewswire/ --

DC Bead LUMI™ provides real-time visible, lasting confirmation of bead location during and post-embolisation of hypervascular tumours in the liver    

BTG plc (LSE: BTG), a global specialist healthcare company, announced today it has received Class III CE Mark certification for DC Bead LUMI™, the first commercially available radiopaque drug-eluting bead (DEB) in the EU which can be loaded with doxorubicin or irinotecan for the local treatment of tumours in patients with hepatocellular carcinoma (HCC) and malignant colorectal cancer metastasised to the liver (mCRC). For the first time, DC Bead LUMI™ provides real-time visible and lasting confirmation of bead location, bringing a new level of control to transarterial chemoembolisation (TACE) procedures. DC Bead LUMI™ is a next-generation development of DC Bead®, the market leading drug-loadable embolic bead.


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Liver cancer is one of the most challenging to treat and is the second leading cause of cancer deaths in the world[1], with around 47,000 deaths per year in the EU.[2] To date, the accuracy of treatment delivery has been based on response to the procedure. The unique visibility of DC Bead LUMI™, both during and after embolisation, provides the opportunity to individualise a patient's treatment, by enabling real-time evaluation of the completeness of tumour treatment and enhanced endpoint determination. The innovative incorporation of a tri-iodobenzyl moiety offers inherent long-term radiopacity of DC Bead LUMI™ allowing informed decision-making for future treatment plans as DC Bead LUMI™ is still visible in follow-up scans, identifying areas of treatment and undertreatment.  

"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," said PD Dr Tobias Jakobs, The Hospital of the Order of St. John of God, Munich, Germany. "More importantly, the lasting radiopacity of DC Bead LUMI™ means I can show patients that treatment has been placed exactly where it's needed."

"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 BeadM1TM," said Duncan Kennedy, BTG Head of Interventional Oncology. "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."

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 endeavors 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 liver tumors, advanced emphysema, severe blood clots, and varicose veins. To learn more about BTG Interventional Medicine, please visit: btg-im.com.

About DC Bead LUMI™

DC Bead LUMI™ is the first commercially available radiopaque drug-eluting bead (DEB) which can be loaded with doxorubicin or irinotecan for the local treatment of tumours in patients with hepatocellular carcinoma (HCC) and malignant colorectal cancer metastasised to the liver (mCRC). DC Bead LUMI™ are precisely calibrated, radiopaque DEB developed using the same core chemistry as the clinically proven DC Bead® . DC Bead LUMI™ contain a covalently bound radiopaque moiety to offer inherent, lasting radiopacity; they are visible under imaging (computed tomography [CT], cone-beam computed tomography [CBCT] and fluoroscopy) providing visible confirmation of bead location during embolisation procedures. The lasting radiopacity of DC Bead LUMI™ means they will also be visible in follow-up scans. For more information, please visit: dcbeadlumi.com.

About DC Bead®

DC Bead® is the only drug-eluting bead with CE Mark approval for loading with doxorubicin or irinotecan, providing an effective standardised liver-directed therapy for primary and metastatic liver cancer. With more than 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.[3]-[7] In metastatic colorectal cancer patients, DC Bead® has been shown to offer improved survival and enhanced quality of life versus systemic chemotherapy alone.[8] For instructions for use and important safety information, please visit: dcbead.com


References:   

  1. World Health Organization (WHO). Cancer factsheet. Available at: http://www.who.int/mediacentre/factsheets/fs297/en/. Last accessed March, 2017.
  2. European Association for the Study of the Liver (EASL). The Burden of Liver Disease in Europe - A Review of Available Epidemiological Data. Available at: http://www.easl.eu/medias/EASLimg/Discover/EU/54ae845caec619f_file.pdf. Last accessed March, 2017.
  3. Lammer J et al. Cardiovasc Intervent Radiol 2010; 33: 41-52.
  4. Song MJ et al. Eur J Gastroenterol Hepatol 2011; 23: 521-7.
  5. Dhanasakeran R et al. J Surg Oncol 2010; 101: 476-80.
  6. Burrel M et al. J Hepatol 2012; 56: 1330-5.
  7. Malagari K et al. Cardiovasc Intervent Radiol 2012; 35: 1119-28.
  8. Fiorentini G et al. Anticancer Res 2012; 32: 1387.