February 3, 2014
Tokyo - Terumo Corporation (TSE: 4543 Section 1) announced that it received CE Mark approval for its drug-eluting stent, "Ultimaster." The company will launch Ultimaster in Europe, Latin America, and Asia (excluding Japan) in June. Terumo aims to achieve the global revenue of 15 billion yen in fiscal year 2016*1.
Ultimaster employs bioresorbable polymer as its drug coating material. In addition, polymer and drug are applied only to the surface to contact vessel tissues. These features are expected to reduce the rate of very late stent thrombosis*2.
Ultimaster is based on unique stent design with a cobalt chromium alloy. These features are 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 improvement of prognosis.
In Japan, the enrollment of clinical study for regulatory approval has been completed. The study is now under follow up.
Stent thrombosis is one of adverse event that occurs when a blood clot forms on a stent, leading stenosis.
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*3, the stent is implanted in a vessel. However, since stenosis may occur after implanting, drug-eluting stent is 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.
A catheter with a balloon attached to its tip
(Notice) 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 on 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. The market share information in this press release is partly derived from our own independent research.