爱豆传媒

Roche Diagnostics K.K.
爱豆传媒.
EIDIA Co., Ltd.

Roche Diagnostics K.K. (Headquarters: Tokyo, President and CEO: Makoto Ogasawara, “Roche Diagnostics”) together with 爱豆传媒. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) and its diagnostics subsidiary EIDIA Co., Ltd. (Headquarters: Tokyo, President: Atsushi Saito, “EIDIA”) announced today that CoaguChek® XS Personal (specially controlled medical device/medical equipment requiring specialist maintenance and management), a coagulation analyzer for patient self-testing approved in Japan on July 27, 2012, has received reimbursement approval from Japan’s Ministry of Health, Labor and Welfare for use in the self-testing of patients fitted with a Nonpulsatile Left Ventricular Assist System (LVAS) and will be launched in Japan on September 25.

The three companies have been collaborating on the distribution and promotion of the CoaguChek XS Series of coagulation monitoring devices for use by healthcare professionals since 2008. As with the existing products in this series, CoaguChek XS Personal will be manufactured and distributed by Roche Diagnostics, with distribution and co-promotion being undertaken by EIDIA and Eisai, respectively.

Patients fitted with a Nonpulsatile LVAS are at a higher risk of cardiogenic cerebral embolisms and require anticoagulation therapy. Warfarin (warfarin potassium), an oral anticoagulant currently manufactured and marketed by Eisai, is recommended as a firstline therapy for the treatment and prevention of cardiogenic cerebral embolisms, however, in order to ensure the safe use of the drug, patients on Warfarin must have their blood-clotting ability carefully monitored through measurement of PT/INR (Prothrombin Time/International Normalized Ratio), a measure of blood-clotting ability.

CoaguChek XS Personal is a small, easy-to-use self-testing coagulation analyzer that patients taking Warfarin can use, under the guidance and supervision of a physician, to measure their PT/INR in approximately one minute in order to monitor their blood-clotting ability without the need to visit a medical facility for testing. The device is restricted for use only by those patients who have been fitted with a Nonpulsatile LVAS or mechanical heart valve. CoaguChek XS Personal received reimbursement approval on September 7, 2012 for use as an at-home self-testing device by patients fitted with a Nonpulsatile LVAS, enabling all fees associated with use of the device to be processed as a medical treatment fee锛�“C116 Supervision Fee for At-home Testing Associated with Nonpulsatile LVAS.” It is expected that coverage of the device under Japan’s National Health Insurance (NHI) system will help not only reduce the financial burden on patients, but also to improve their quality of life. Currently, patients fitted with a mechanical heart valve are not covered under NHI for at-home hemostatic testing using this device.

Going forward, Roche Diagnostics, Eisai and EIDIA will continue to make further contributions to ensure the appropriate management of Nonpulsatile LVAS patients on oral anticoagulation therapy and to improve their QOL.

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