Terumo Initiates World-Wide NOBORI 2 e-Registry

April 4th, 2008

Tokyo, Japan, Leuven, Belgium – April 4, 2008 – Terumo Corporation, announced today enrolment of the first patient in the NOBORI 2 study designed to further confirm the safety and efficacy of the Nobori® Drug-Eluting Coronary Stent System.

“We are very pleased to enrol the first patient in the NOBORI 2 registry which is expected to generate invaluable long term data about Nobori® stent. The stent was easily delivered and performed well” said Dr. K.E. Hauptmann from Krankenhaus der Barmherzigen Brüder, Trier, Germany, a member of the NOBORI 2 Steering committee.
“Nobori® is not considered as yet another drug eluting stent, but rather as a promising, new treatment option for our patients”, said Dr. M. Wiemer of the Herz- und Diabeteszentrum NRW in Bad Oeynhausen, Germany, the Coordinating investigator for Germany.

The NOBORI 2 is the prospective, multi-center, real-life study to validate the safety and effectiveness of Nobori® stent in 3000 patients to be enrolled in more than 20 countries in Europe, Asia, New Zealand and Africa. The primary endpoint is a composite of cardiac death, myocardial infarction and clinically justified target lesion revascularization at 12 months post-procedure. Other major endpoints this study will assess are duration of dual antiplatelet therapy and stent thrombosis in the period up to 5 years.

“NOBORI 2 will allow us to better understand the efficacy and long term safety of the Nobori® stent, in a real life setting” said Dr. G.B. Danzi, of the Ospedale Maggiore Policlinico, Milan, Italy, the Principal Investigator of NOBORI 2. “Extensive monitoring, electronic data collection independent adverse events adjudication and prespecified subgroups analysis make the NOBORI 2 a distinctive and highly valuable study” added Dr. Danzi.

The Nobori® stent with bioresorbable polymer and abluminal coating is a truly new generation drug eluting stent. Nobori’s excellent efficacy and safety have been confirmed through several clinical trials including NOBORI 1 with its two phases, NOBORI CORE and NOBORI Pharmacokinetics study.

“The NOBORI 2 is the key launching event for the Nobori® stent which will further expand our comprehensive product portfolio in interventional cardiology”, said Hideo Arase, President and CEO of Terumo Europe N.V.. “With combination of Tsunami BMS and Nobori® DES together with other PCI products, Terumo will provide safe and effective options for broad range of patients with coronary artery disease”.

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 renowned proprietary M Coat® hydrophilic coating for enhances deliverability to challenging lesions.

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 and vascular intervention 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 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.

For more information:

Nori Kunimoto
nobori@terumo-europe.com