LONDON, August 2, 2016 /PRNewswire/ --
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 BeadM1TM as Class III
medical devices under Rule 8 of Annex IX to Directive
93/42/EEC.
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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.
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.
About DC
Bead®
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.1-5 In
metastatic colorectal cancer patients, DC Bead® has been
shown to offer improved survival and enhanced quality of life
versus systemic chemotherapy alone.6 For instructions
for use and important safety information, please visit:
dcbead.com
References:
Lammer J et al. Cardiovasc Intervent Radiol 2010; 33: 41-52.
Song MJ et al. Eur J Gastroenterol Hepatol 2011; 23: 521-7.
Dhanasakeran R et al. J Surg Oncol 2010; 101: 476-80.
Burrel M et al. J Hepatol 2012; 56: 1330-5.
Malagari K et al. Cardiovasc Intervent Radiol 2012; 35:
1119-28.
Fiorentini G et al. Anticancer Res 2012; 32: 1387.
For further information contact:
BTG plc
Chris Sampson
Corporate Communications Director
+44-20-7575-1595
Mobile: +44-7773-251-178
Media Liaison
Jonathan Falcone
+44-208-618-2752; Mobile: +44-7825-238-898
SOURCE BTG plc