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Terumo Acquires CE Marking for Kanshas Drug Coated Balloon Catheter for Lower Extremities

20/06/2018 - Tokyo, Japan

Terumo Corporation (TSE: 4543) today announced that it acquired CE marking for the Kanshas™ drug coated balloon (DCB) catheter used in the treatment of lower extremity peripheral arterial disease. With a September launch in Europe, Terumo is expected to be the first Japanese company to launch DCB sales in Europe, and the European launch will be followed with launches in Latin America and Asia, as well. Terumo aims a 10% share of the European DCB market in the future.

Peripheral arterial disease is a condition in which blood vessels narrow and blood flow deteriorates due to arteriosclerosis in the legs, and it has become more prevalent in recent years due to aging populations and lifestyle diseases. This treatment procedure uses a small balloon at the end of a thin catheter to dilate narrowed blood vessels in lesions, and it has been popular around the world because it provides a less invasive treatment option for patients.

A drug coated balloon catheter is a medical device coated with a drug that suppresses cell proliferation on the balloon surface. When the balloon is expanded, it comes into contact with the blood vessel walls, transferring the drug to the vascular tissues, which is expected to suppress restenosis.

Kanshas™can be expected to have an enhanced therapeutic effect due to Terumo’s proprietary uniform micro-crystal coating named Unicoat™, which has been designed so that the coated drug is less likely to migrate before it reaches the lesion and then transfers swiftly to vascular tissue when the balloon is expanded. Product lineup of long balloon with a range up to 200mm can be treated for long lesions, which are common in the lower extremities.

Terumo is aiming to expand its peripheral vascular intervention business globally and is building up its product portfolio. The launch of Kanshas™ is part of this strategy. Going forward, Terumo is determined to enhance its contribution to medical treatment in the endovascular field.

About Terumo Corporation

Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with over $5 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 health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.


(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.