Terumo Receives Approval for the Manufacturer and Sale of its Ultimaster Drug-Eluting Coronary Stent in Japan

Terumo Corporation (Headquarters: Shibuya-ku, Tokyo, Japan; President: Yutaro Shintaku) announced today that it has received approval for manufacturing and selling its Ultimaster drug-eluting coronary stent (DES) in Japan. Since first releasing Ultimaster in Europe in May 2014, Terumo has gone on to sell the product in more than 40 countries in Asia and Latin America. The sales release in Japan is scheduled for October 2015.

DES used in Japan in a majority of interventional treatments of myocardial infarction and other coronary events

A stent is a medical implant device used in the treatment of angina pectoris, myocardial infarction, and other coronary events caused by stenosed or blocked blood vessels (coronary arteries) that send nourishment to the heart. In Japan, stents are used in approximately 200,000 cases every year.

After a stent is implanted in a blood vessel, the vessel may become restricted again, causing tissue proliferation or other complications. This is why DES have come into use in a majority of treatments, as the drug can be gradually released to the surrounding tissues, which is expected to reduce such tissue proliferation.

Terumo's original bioresorbable polymer and drug coating technology is expected to help lower the frequency of thrombosis

For Ultimaster, Terumo adopted bioresorbable polymer as the drug coating material and coated only the outer surface that comes into contact with the blood vessel tissues with the polymer and drug. For this reason, Ultimaster is expected to help lower the frequency of stent thrombosis^* cases over the long term.

Furthermore, Terumo used cobalt chromium alloy as the material and devised a unique design that makes it easier to navigate the stent through the blood vessels and implant it along the curvature of the vessels. The aim of this design was to reduce stress on the blood vessel walls and improve medical prognosis.

Part of the stent after it has been dilated

With Terumo's original drug coating technology, the drug is released efficiently into the blood vessel tissues, after the stent is dilated

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  Stent thrombosis is a complication that occurs when a blood clot forms inside an implanted stent and constricts or blocks the passageway of the stent.