Terumo receives CE Mark approval for the line extension on Drug-eluting Stent, Ultimaster® to advance the treatment of coronary artery disease

Leuven, Belgium - December 4, 2014

Terumo Corporation (TSE: 4543 Section 1) announced that it continues to expand its portfolio and received CE Mark^*1 approval for line extension of its drug-eluting stent, "Ultimaster". With this product line extension there are now 48 items with a diameter ranging from 2.25 mm to 4 mm and lengths from 9 mm to 38 mm available. Following the clinical practice in interventional cardiology, the highly deliverable Ultimaster DES will be available with completed product portfolio to increase treatment option for wider range of lesions.

Terumo expects to launch the new size 2.25 mm and further lengths of 33 mm and 38 mm for all stent diameters until Fiscal Year Ending March 2015, following the full launch of the recently CE-approved Ultimaster DES.

Since the launch Terumo has received extremely positive feedback from European physicians on the outstanding performance of this effective and easy-to-use stent system. Physicians benefit from the excellent deliverability, conformability, and flexibility of this product as it helps to provide safe and optimal outcomes for patients by maximising efficiency.

"I am honoured and happy to hear that physicians appreciate treating their patients successfully with the Ultimaster Drug Eluting Stent. The fact that we now can deliver all lengths and diameters will increase the possibility to provide high quality products to patients in need of this treatment," said Peter Coenen, President of Terumo Interventional Systems, EMEA.

The Ultimaster design hypothesis is strongly supported by robust clinical evidence from the comprehensive clinical program. The results of CENTURY study confirmed high efficacy of Ultimaster DES with late loss at 6 months of 0.04 mm and OCT assessed Ultimaster stent strut coverage of 96.2 ±5.4%. At two years, the rate of target lesion revascularisation^*2< was 2.9%, the rate of target lesion failure^*3 5.7% with no late or very late stent thrombosis^*4. CENTURY II study is a global, multicenter, randomised trial that enrolled 1123 complex patients in 58 hospitals in 13 countries including Japan. At 9-month the Ultimaster DES fully matched the performance of Xience DES with 95.64% of patients being free of any target lesion failure as compared to 95.09% in Xience treated patients. Several additional ongoing studies with Ultimaster DES are designed to further confirm excellent performance of this innovative stent in patients with acute myocardial infarction (MASTER study), in small vessels (CENTURY SV study), to assess potential for reduced dual antiplatelet therapy (DISCOVERY 1TO3) or to highlight performance in consecutive patients treated in daily interventional practice (e-ULTIMASTER).

A stent is an implant device used in the treatment of angina pectoris, myocardial infarction, and other coronary events caused by blood vessels around the heart (coronary artery) that are stenosed or blocked. After expanding coronary artery with a balloon catheter^*5, the stent is implanted in the vessel. However, since stenosis may occur after implanting, drug-eluting stent are often used.

Drug-eluting stent is expected to reduce tissue proliferation that may cause restenosis (narrowing of the treated part of the vessel) because its drug is gradually released to surrounding tissues.

• *1:

  The CE Mark indicates that the product complies with the requirements of the applicable EU Directives (EU : The European Union) and all medical devices need to be CE certified to be sold in Europe.

• *2:

  Target lesion revascularisation - renarrowing of treated lesion requiring repeated procedure.

• *3:

  Target lesion failure - composite of cardiac death, myocardial infarction and target lesion revascularisation.

• *4:

  Stent thrombosis is one of adverse event that occurs when a blood clot forms on a stent, leading to serious adverse events.

• *5:

  A catheter with a balloon attached to its tip.