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.
The Nobori® stent system utilizes Biolimus A9™, 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.
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 A9™ 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.
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