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Terumo Announces First CE Certified Nobori™ DES in Use

15/02/2008 - Tokyo, Japan

Terumo Corporation, announced today that the first CE certified Nobori™ Drug-Eluting Coronary Stent System was successfully implanted in Europe. 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 expand the product from spring time 2008 widely to more than 20 countries in Europe, Asia, New Zealand and Africa.

The procedure was performed by Dr. Antonio Colombo, director of the Cardiac Catheterization Laboratory at Columbus Hospital and San Raffaele Hospital, Milan Italy in a live case transmission during JIM congress held in Rome.

"I successfully finished this highly tortuous right coronary case using Nobori™ Drug-Eluting Coronary Stent System. It looks very promising. I look forward to seeing this new generation stent in daily use." said Dr. Antonio Colombo.

On January 16th 2008 Nobori™, as a first drug eluting stent employing bioresorbable polymer and drug Biolimus A9™, received CE Certificate. The launch of Nobori™ stent will incorporate comprehensive clinical program to characterize the stent's long-term safety and efficacy in a variety of patient populations. The program will enrol more than 5,000 patients in randomized trials and post-marketing registry.

The excellent efficacy and safety of the Nobori™ stent have been confirmed through the several clinical trials included NOBORI 1 with its two phases, NOBORI CORE and NOBORI Pharmacokinetics study. In randomized studies versus Taxus Express® and Taxus Liberté® 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 other well known DES, 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.

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