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March 05, 2012

Leuven, Belgium (February 10, 2012) - The recently published two-year data from the large NOBORI 2 study confirmed the excellent and sustained performance of the Nobori® drug eluting stent (DES) when used in high risk unselected patients. NOBORI 2 is a prospective, open-label, single arm, multi-centre study that enrolled 3067 patients with 5463 lesions in 125 centers in Europe and Asia who were treated with a Nobori DES1. The complexity of the patient population enrolled in the study is fully representative of contemporary percutaneous coronary intervention practice with 53% of the patients having multi-vessel disease, 54% presenting in the course of acute coronary syndrome, 30% suffering from diabetes mellitus, and more than 20% with lesions at bifurcation

Clinical Outcomes at 2 Years

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MI=Myocardial Infarction, TLR=Target Lesion Revascularization; TLF=Target Lesion Failure; ST= Stent Thrombosis (Definite and probable according to ARC definition)

1 Danzi GB et al.: Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: the NOBORI 2 study. EuroIntervention 2012 Jan 26. pii: 20111230-03 [Epub ahead of print]

The high compliance with follow-up at both one and two years in the NOBORI 2 study further reinforces the validity of the results.

"The observed low rate of late and very late stent thrombosis in this study that enrolled a highly complex patient population adds evidence to the hypothesis that DES with biodegradable polymer may have better long term safety as compared to the first generation of these devices," commented Dr. Gian Battista Danzi, Ospedale Maggiore, Milan Italy, the Principal Investigator of the study.

"We are very encouraged by the results of NOBORI 2 as the ultimate goal of all Terumo technologies is to bring benefit to patients", said Mr. Toshi Osada, President of Terumo Europe Interventional Systems.

The results of the NOBORI 2 study are in agreement with and complement previous trials of the comprehensive NOBORI clinical program providing proof of the very good safety and efficacy profiles of the stent both, in simpler cases and in patients with high-risk clinical and anatomic features.

About Nobori® stent

The Nobori® DES stent system has a unique design concept with a matrix of biodegradable, polymer polylactic acid (PLA) and the antiproliferative drug Biolimus A9™ (Biosensors International), coated only abluminally on the highly flexible stent platform. PLA polymer in the Nobori® DES system degrades primarily by hydrolysis and the degradation product, water-soluble lactic acid, is absorbed by tissue and is eventually converted to water and carbon dioxide. The precise drug release kinetic of the Nobori® stent matches the biological response to procedure-induced injury with a burst release immediately after stent implantation and continuous drug release along with polymer degradation to further prevent neointima growth.

About Terumo

Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.

Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. Accordingly, it should be noted that actual results may differ from those forecasts or projections due to various factors. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition.

 

Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice.