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Terumo Receives CE Mark for Its New Drug-eluting Stent, Ultimaster™

18/02/2014 - Leuven, Belgium

Tokyo – Terumo Corporation (TSE: 4543 Section 1) announced that it received CE Mark*1 approval for its drug-eluting stent, “Ultimaster”.

The company will launch Ultimaster DES in Europe, Latin America, and Asia (excluding Japan) in June 2014.

Ultimaster employs bioresorbable polymer applied only to the vessel contacting surface to ensure targeted drug delivery. Moreover the polymer and the drug are released simultaneously and within 3-4 months to eliminate long-term polymer exposure, a possible cause of late adverse events. These features are expected to reduce stent thrombosis*2 and to produce favorable long term clinical outcomes.

The Ultimaster DES is based on bio-ergonomic*3 stent design with a cobalt chromium alloy. Favorably low width/thickness of the stent struts enhances stent conformability to the vessel wall and faster healing process that could lead to better strut coverage. The platform is designed to enable the physicians to navigate the stent in tortuous anatomy and facilitate placement of the stent conformable to vessel curvature, further reducing stress on vessel wall for the aim of long-term patency.

“Ultimaster is a masterpiece of drug eluting stent with bioresorbable polymer, underpinned by our accumulated experience and expertise as a leading company in the technology,” said Hikaru Samejima, President of Terumo Interventional Systems. “Terumo will continue its commitment to innovation for true benefits for patients and physicians to provide genuine value to health care society.”

Design hypothesis is further 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 0.04mm. Despite the low late loss, the OCT assessed Ultimaster stent strut coverage at 6 months was 96.2±5.4%. At 12 months, the rate of target lesion revascularisation*4 was 2.8%, the rate of target lesion failure*5 2.9%, MACE*6 3.8%, with only one acute stent thrombosis. CENTURY II study is global, multicenter, randomized trial that enrolled 1123 patients in 58 hospitals in 13 countries. The primary endpoint results will be reported at the upcoming PCR 2014. There are additional studies on-going with Ultimaster Stent, including studies that potentially would pave the way for reduced dual antiplatelet therapy.

*1: The CE Mark indicates that the product satisfies requirements of EU Directives (EU:The European Union) and all products need to be CE certified to be sold in Europe.
*2: Stent thrombosis is one of adverse event that occurs when a blood clot forms on a stent, leading stenosis.
*3: Bio-ergonomic stent design - the platform comprises of small curvatures like snake scale.
*4: Target lesion revascularization - renarrowing of treated lesion requiring repeated procedure.
*5: Target lesion failure - composite of cardiac death, myocardial infarction and target lesion revascularization.
*6: MACE - composite of cardiac death, myocardial infarction and target vessel revascularization.

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*7, the stent is implanted in a 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.

*7: A catheter with a balloon attached to its tip

About Terumo Corporation

Tokyo-based Terumo Corporation is one of the world’s leading medical device manufacturers with $4 billion in sales and operations in more than 160 nations. Founded in 1921, the company develops, manufactures, and distributes world-class medical devices including products for use in cardiothoracic surgery, interventional procedures, and transfusion medicine; the company also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use. Terumo contributes to society by providing valued products and services to the healthcare market and by responding to the needs of healthcare providers and the people they serve. Terumo Corporation’s shares are listed on the first section of the Tokyo Stock Exchange and is a component of the Nikkei, Japan’s leading stock index.

For more information, contact Olivier Archer, Terumo Europe N.V., +33 1 39 30 47 53
Olivier.Archer@terumo-europe.com