March 25 , 2009
Terumo completes enrolment of 3000 patients in NOBORI 2
– a Nobori® Drug Eluting Stent Trial
Tokyo, Japan, Leuven, Belgium – 23 March 2008 – Terumo Corporation announced today that the enrolment of 3000 patients was completed in the NOBORI 2 clinical trial.
NOBORI 2 is a prospective, multi-center, real-life study to validate the safety and effectiveness of the Nobori® stent in 3000 consecutive patients enrolled in routine daily practice in 129 centres across more than 20 countries and 3 continents. The primary endpoint is a device-oriented composite of cardiac death, myocardial infarction and target lesion revascularization at 12 months post-procedure.
"The data collected from the 3000 patients, treated with Nobori® drug eluting stent in the large scale NOBORI 2 study will allow us to increase understanding about the efficacy and long term safety of this most innovative drug eluting stent, in a truly representative patients population" said Dr Gian Battista Danzi, of the Ospedale Maggiore Policlinico, Milan, Italy, the Principal Investigator of NOBORI 2 study. "Particularly appealing is the expected quality of data from this trial with anticipated 100% on-line monitoring, on-site monitoring for the first 1000 patients and 30% of additional 2000 patients, and all serious adverse events", added Dr Danzi.
The Nobori® stent system is a truly new generation drug eluting stent (DES) with a bioresorbable polymer, offering best in class clinical results, excellent deliverability and strong patient safety profile.
The excellent efficacy and safety of the Nobori® stent have been established in several clinical trials including NOBORI 1, NOBORI CORE and NOBORI Pharmacokinetics study. Compared with Taxus Express® and Taxus Liberté® in randomized studies, the Nobori® stent proved its non-inferiority and even superiority in efficacy endpoints such as in-stent late loss, with low frequency of adverse cardiac events and no stent thrombosis. In NOBORI CORE, a comparative study versus Cypher® stent, another DES, Nobori® again showed excellent performance with very low rate of adverse cardiac events. The overall restenosis rate in all NOBORI trials was as low as 0.5% and no late stent thrombosis was recorded in any of the trials.
About Nobori® stent
The Nobori® stent system utilizes Biolimus A9TM, an analogue of sirolimus which is expected to reduce tissue proliferation and which is eluted from a bioresorbable polymer, poly-lactic acid. The stent delivery system applies Terumo's proprietary hydrophilic coating which enhances deliverability and reduces arterial wall damage.
About Terumo
Terumo is a global health care company dedicated to the research, development, manufacturing and marketing of products used in a wide range of medical applications. For more information, please visit www.terumo.com.
Biolimus A9TM and technology of its elution from bio-resorbable polymer (poly-lactic acid) is a proprietary of Biosensors International. In 2003 Terumo signed a licensing agreement with Biosensors for the development and marketing of a drug eluting stent.
(Note) Forward-looking statements included in this release were determined by Terumo based on the best information available at the time of writing and are subject to potential risks and uncertainties. Therefore, please note that, due to various factors, the actual implementation may differ from what is described here.
