October 25, 2006Terumo’s Nobori™ Drug-Eluting Coronary Stent confirmed non-inferior to Taxus® Express in NOBORI 1 first phase Clinical TrialStudy Demonstrates Excellent Results for Nobori™ Stent SystemLeuven, Belgium, Tokyo, Japan and Washington D.C. -- 24 October, 2006 -- Very positive nine-month results of Terumo's NOBORI 1 clinical trial of the Nobori™ Biolimus A9-eluting coronary stent system were presented today at TCT in Washington D.C., U.S.A. Results of the trial, which was conducted in Europe, Asia and Australia, demonstrated non-inferiority of Nobori™ stent system to the TAXUS® paclitaxel- eluting coronary stent system with respect to the study's primary endpoint, which was angiographic in-stent late loss at nine months (0.15 +/- 0.27 mm for Nobori™ vs. 0.32 +/- 0.33 mm for TAXUS®, p<0.006). Late loss is a measurement of the re-narrowing of the vessel caused by tissue growth inside the stent. Secondary endpoints of the trial also demonstrated excellent results for the Nobori™ stent system, including a statistically significant reduction in percent volume obstruction, measured by IVUS, from 8.9% for TAXUS® to 2.2% for Nobori™ stent (p<0.017). The in-stent and in-segment angiographic binary restenosis rate representing percentage of patients with vessel occlusions 50 percent or greater, at nine-month follow up, for Nobori™ stent was 0 percent. Ultimately the need for clinically driven repeat intervention on the treated site was also 0 percent. No deaths and post-procedural myocardial infarction were recorded in this trial indicating good safety of Nobori™ stent.
Nobori™ DES is currently an investigational device in Europe, Asia and Australia. The system utilizes Biolimus A9,an anti-inflammatory and anti-proliferative compound, specifically developed for stent application. Contrary to other drug eluting stents Nobori™ DES employs bioresorbable polymer, poly-lactic acid. The combination of drug which has been shown to prevent tissue proliferation and polymer which is resorbed in the tissue is expected to show both high efficacy and safety.
NOBORI 1 is a 360-patient prospective randomized (2:1) clinical trial, evaluating Nobori™ versus TAXUS® coronary stent system in 29 centres across Europe, Asia and Australia. Unlike majority of other DES trials, NOBORI 1 trial used currently marketed DES as comparator and also allowed treatment of two coronary arteries, considered as a higher risk procedure. This time, the result of 1st phase enrolling 120 patients became available. The company also announced the completion of the enrolment in the 2nd phase last week, for which the 9 month follow up results are expected around summer 2007. About TerumoTerumo Corporation, Tokyo, Japan, is a premier global medical company with 2005 annual sales in excess of $2.11 billion and TERUMO Europe NV is an affiliate of the company in Europe. Terumo Corporation develops, manufactures, and markets a wide range of medical products including cardiovascular systems, disposable medical devices, therapeutic catheters, I.V. solutions, blood bags, diabetes care systems, and medical electronic products in more than 150 countries. In October 2003, Terumo Corporation and Biosensors International, signed a licensing agreement on drug eluting stent development and marketing.Biolimus A9 is proprietary to Biosensors International. (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. |
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