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German Patient Survives 5 Years With DuraHeart Assist Device

Ann Arbor-based Terumo Heart Inc., a wholly owned subsidiary of Japan's Terumo Corp., Tuesday announced that a patient implanted with the DuraHeart Left Ventricular Assist System has surpassed five years of support on the mechanical circulatory support device.

Helga Gieseke, living in Germany, was treated at The Deutsches Herzzentrum Berlin (which translates as "German Heart Institute Berlin") and is now one of the longest-living heart failure recipients of the DuraHeart device.

"Now I can breathe again," Gieseke said. "For years before I received the DuraHeart I was unable to do anything with my children or grandchildren. Since the DuraHeart, I was able to experience the birth of my little grandchild ... I can now do things like walk and play catch and am able to participate in the lives of my family."

Gieseke's heart problems have been occurring since the 1980's; her first heart surgery was performed in 1994. Between 1994 and 2006, Gieseke underwent several procedures including implantation of stents, pacemakers and implantable defibrillators in an attempt to manage her condition. Despite all these treatments, Gieseke's condition continued to deteriorate until she found herself unable to walk or carry out simple activities without experiencing chest pain and being short of breath.

Gieseke admits that without the DuraHeart, she would probably not have lived to see her most recent birthday.

"DuraHeart was my only option; there is a shortage of donor organs, and DuraHeart was my last chance." she said. "My family supported my decision and we have all been extremely happy with the decision and the quality of life the DuraHeart has afforded me."

Said William Pinon, president and CEO of Terumo Heart: "It is so gratifying to see patients such as Mrs. Gieseke who have been able to proceed with their lives following the implantation of the DuraHeart LVAS. Mrs. Gieseke is a prime example of how someone who was in declining health can lead a fulfilling life with end stage heart failure."

The DuraHeart LVAS is a rotary blood pump designed for long-term patient support. The system incorporates a centrifugal flow rotary pump with the magnetically levitated impeller. The pump features three position sensors and electromagnetic coils that suspend the impeller inside the pump chamber without a single contact point. The impeller's active magnetic levitation is designed to eliminate friction by allowing a wide gap between blood contacting surfaces, enabling blood to flow through the pump unimpeded in a smooth, non-turbulent fashion.

The DuraHeart LVAS carries a CE Mark and is currently available for sale in Japan and Europe.  DuraHeart is limited to investigational use only in the United States. For more information about heart failure, Ventricular Assist Devices or the DuraHeart LVAS, visit www.terumoheart.com.

More than 22 million people suffer from heart failure worldwide with approximately one million new patients diagnosed annually. In the setting of an aging global population, heart failure is the No. 1 reason for hospitalization. The most severely ill patients need heart transplants in order to recover. More than 8,000 people worldwide are on the list of eligible candidates for heart transplants annually, but less than 3,000 receive a transplant each year.  A large number of people who suffer from severe heart failure do not qualify for transplantation due to other health issues. An alternative for these patients is access to artificial mechanical assist.

Terumo Heart is a subsidiary of Terumo Corp. with headquarters and manufacturing in Ann Arbor. The company's focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Terumo Corp., located in Tokyo, Japan, is a leading developer, manufacturer and global marketer of a wide array of medical products. DuraHeart is limited to investigational use only in the United States, and is CE marked in Europe. For more information visit www.terumoheart.com

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