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June 10, 2016

Tokyo Japan - June 10, 2016 - Terumo Corporation announced that Terumo Cardiovascular Systems (Terumo CVS) received notice from the U.S. Food and Drug Administration (FDA) that it has successfully completed the second and final phase of its work plan to remediate all products manufactured or distributed from Terumo's Ann Arbor, Michigan manufacturing facility, including Terumo® Advanced Perfusion System 1. As a result, all shipping restrictions, imposed as a term of its 2011 consent decree, are now lifted.

In a letter dated June 8, 2016, the FDA concludes: "Terumo is no longer enjoined under Paragraph 5 of the Consent Decree from manufacturing, packing, storing, installing, and/or distributing the above listed products from the Ann Arbor Facility." The letter followed the FDA's inspection of the facility in early May during which the agency found no inspectional observations.

The Ann Arbor manufacturing facility designs, produces, and distributes electromechanical devices used in cardiac surgery, such as heart-lung machines and blood parameter monitoring systems. The FDA considers some of these devices 'life-sustaining,' a category of devices that requires a robust Quality Management System commensurate with these types of devices.

Terumo CVS agreed to the shipping restrictions in 2011 as a condition of its consent decree with the FDA. Under the terms of the consent decree, Terumo CVS would create and execute a work plan to address the FDA's concerns with the Quality Management System at the Ann Arbor facility. In addition, Terumo CVS would restrict distribution of products manufactured at the plant until the work plan was complete.

Terumo CVS completed the first phase of a two-phase work plan in December, 2014. After a subsequent inspection of the facility, the FDA determined in February, 2015 that Ann Arbor's general Quality Management System, as well as processes specific to its CDI® Blood Parameter Monitors, were in compliance with regulation and it lifted shipping restrictions on the monitors.

Terumo CVS completed the second and final phase of its work plan in February, 2016, leading to the FDA's inspection in May.

Terumo CVS will resume distribution of its monitoring systems this summer and expects to scale up production of its heart-lung machines after it completes several engineering projects to manage obsolescence issues.

"This means we have demonstrated to the FDA that we have the Quality System and infrastructure needed to manufacture life-sustaining devices in full compliance with the FDA regulation," says Mark Sutter, President and CEO, Terumo CVS. "But most importantly for all of our employees and our customers, it means that our Ann Arbor facility is now stronger and in a better position to serve our customers. We are looking forward to fulfilling our company's mission of helping save lives."。

The consent decree did not impact the production or distribution of products manufactured at Terumo CVS' other factories, including oxygenators for which Terumo is a global market leader. Nor did it impact any other Terumo subsidiary or corporate entity.

About Terumo Cardiovascular Systems

About Terumo

Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 years. Based in Tokyo and operating globally, Terumo employs more than 28,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer, and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.

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 or 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.

 

Information about products (including products currently in development) included in this material is not intended to constitute an advertisement or medical advice.