October 23, 2007TERUMO’S NOBORI™ DRUG ELUTING STENT SYSTEM CONTINUES TO SHOW EXCELLENT RESULTSTokyo, Japan; Leuven, Belgium; Washington DC, USA; October, 22, 2007. Positive 9-months results of Terumo’s NOBORI 1, second phase clinical trial of Nobori™ Drug Eluting Stent (DES) system were presented today at Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington DC. Results of the trial, which was conducted in 29 centers across Europe, Asia and Australia, demonstrated non-inferiority of the Nobori™ stent system compared to Taxus® Liberte™ stent system, with respect to the study’s primary endpoint of angiographic in-stent late loss at 9-months (0.11±0.30 mm for Nobori™, vs. 0.32±0.51 mm for Taxus® Liberte™, p<0.001). The superiority of Nobori™ versus Taxus® Liberte™ for the same endpoint, which was a secondary objective, has also been confirmed (p=0.001). Late loss is the measure of change in the vessel diameter between the time immediately after the procedure and at nine-months. Major secondary endpoints showed superior results for the Nobori™ stent system including a significant reduction in angiographic binary restenosis rate and percent diameter stenosis at 9-months. Furthermore, the intravascular ultrasound findings favor Nobori™ with significantly lower in-stent volume obstruction. The 9-months Major Adverse Cardiac Events (MACE) rate for Nobori™ was 3.9-percent versus 5.6-percent for Taxus®. As defined in NOBORI 1 clinical trial the MACE rate includes cardiac death, heart attacks, and target vessel revascularization at 9-months. One of the most striking findings of this clinical trial is 0-percent Stent thrombosis rate for the Nobori™ stent versus 4.4-percent rate for the Taxus® Liberte™ stent. Stent thrombosis had been one of the gravest safety concerns for interventional cardiologists.
About Nobori™ stentThe Nobori™ stent system utilizes Biolimus A9™, an analogue of sirolimus which is expected to reduce tissue proliferation and which is eluted from a biodegradable polymer, poly-lactic acid. The stent delivery system applies Terumo’s proprietary hydrophilic coating which enhances deliverability and reduces arterial wall damage. About NOBORI 1 clinical trialNOBORI 1 is a 360-patient prospective, randomized (2:1), two phase clinical trial, evaluating Nobori™ versus Taxus® coronary stent system in 29 centers across Europe, Asia and Australia. The NOBORI 1 trial allowed treatment of up to two coronary arteries, considered as a higher risk procedure. The results of the first phase which randomized Nobori™ versus Taxus® Express™ were reported in 2006, while the current presentation included the final results of the second phase, which enrolled 243 patients (153 in Nobori™ and 90 in Taxus® Liberte™ arm). About TerumoTerumo is a global health care company dedicated to research, development manufacturing and marketing of medical products and equipment, including pharmaceuticals, nutritional food supplement, blood bags, disposable medical devices, cardiovascular systems, vascular grafts, peritoneal dialysis, blood glucose monitoring system, medical electronic, and digital thermometers. The main company vision is to contribute to the society through health care using its unique technology which makes medical treatment kinder and gentler. Terumo employs more than 12.000 people and its products are available in over 150 countries world-wide. Biolimus A9™ and technology of its elution from biodegradable polymer (poly-lactic acid) is a proprietary of Biosensors International with whom Terumo, in the year 2003, signed a licensing agreement for the development and marketing of 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. |
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