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Terumo receives CE Certificate for Nobori™ Drug-Eluting Stent

18/01/2008 - Tokyo, Japan

Terumo Corporation, announced today that it has received CE certificate for the commercial sale of the Nobori™ Drug-Eluting Coronary Stent System in European Economic Area. 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 company intends to launch the product shortly and to expand to more than 20 countries during the first quarter of fiscal year 08.

Regulatory approval of the Nobori™ stent was based on exceptional clinical data obtained in a comprehensive NOBORI clinical program. The program included NOBORI 1 with its two phases, NOBORI CORE and NOBORI Pharmacokinetics study. In randomized studies versus Taxus Express® and Taxus Libertè® the Nobori™ stent proved its non-inferiority and even superiority in efficacy endpoints such as late loss, with an exceptionally low frequency of adverse cardiac events and no stent thrombosis up to 1 year in phase 1 and 9 months in phase 2. In NOBORI CORE, a comparative study versus Cypher® stent, Nobori™ also 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.

Terumo plans additional clinical activities with the Nobori™ stent as part of a comprehensive program to characterize the stent's long-term safety and efficacy in a variety of patient populations. The program will enroll more than 5,000 patients in randomized trials and post-marketing registry in Europe, Asia, New Zealand and Africa.

"The Nobori™ drug-eluting stent represents an extraordinary achievement of our research, development, manufacturing, clinical and regulatory people and adds an important product to our robust portfolio. The regulatory approval of the Nobori™ stent in Europe and related activities in our home market demonstrate Terumo's commitment to interventional cardiology," said Yutaro Shintaku, Group President, Cardiac & Vascular Business, Terumo Corporation.

"Our sales and marketing people are fully trained and ready to take up the challenge of launching the Nobori™ stent. With two excellent stent systems, Tsunami™ BMS (bare metal stent) and Nobori™ DES, Terumo will be able to offer safe and effective treatment options for broad range of patients with coronary artery disease", said President and CEO of Terumo Europe N.V.

About Nobori™ stent

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.

About Terumo

Terumo 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 160 countries world-wide.

Biolimus A9™ and technology of its elution from bioresorbable 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. Clinical results of Nobori™ stent were also used for the regulatory approval of Biosensor's drug eluting stent.

For more information

Nori Kunimoto - nobori@terumo-europe.com