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Terumo Heart, Inc. Reports Clinical Progress in the DuraHeart(TM) U.S. Pivotal Trial as NewYork-Presbyterian Hospital/Columbia University Medical Center Implants First Patient

Posted on: Monday, 9 March 2009, 06:00 CDT

ANN ARBOR, Mich., March 9 /PRNewswire/ -- Terumo Heart, Inc. today announced that NewYork-Presbyterian Hospital/Columbia University Medical Center recently became the second U.S. center, and first in the Northeast, to implant the DuraHeart(TM) Left-Ventricular Assist System as part of the DuraHeart Bridge-To-Transplant U.S. pivotal trial, a multi-center, prospective, non-randomized study, involving 140 patients in up to 40 centers nationwide. The trial will evaluate the safety and efficacy of the device in helping to sustain patients awaiting heart transplant who are at risk of death due to end-state left ventricular failure.

The medical team led by Yoshifumi Naka, M.D., Ph.D., director of cardiac transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center and associate professor of surgery at Columbia University College of Physicians and Surgeons, elected to implant the DuraHeart(TM) System using an "off-pump" procedure, allowing him to operate directly on the beating heart, thus reducing the risk for perioperative bleeding and stroke associated with having a patient on bypass.

"We are pleased to be a part of this landmark trial evaluating this third-generation mechanical heart pump, one of the first of its kind to enter clinical trials in the U.S.," said Dr. Naka, who serves as co-principal investigator of the DuraHeart Trial.

"It is extremely gratifying for us to count Dr. Naka's team among those elite institutions who are investigating Terumo Heart's DuraHeart System and building the empirical body of evidence to support the eventual U.S. approval of this important device," said Chisato Nojiri, M.D., Ph.D., Chairperson and Chief Medical Officer, Terumo Heart, Inc. "As a company, we are committed to investing in the resources that will ultimately deliver the most advanced left-ventricular assist device available to help patients retain a healthy and meaningful quality of life while awaiting a heart transplant or ultimately as a long-term solution to a failing heart."

The DuraHeart Trial is sponsored by Terumo Heart, Inc., maker of the DuraHeart System and a wholly owned subsidiary of Terumo Corporation. The DuraHeart System is the first third-generation rotary blood pump designed for long-term patient support that incorporates a centrifugal flow rotary pump with an active magnetically levitated impeller featuring three position sensors and magnetic coils that optimize blood flow, while minimizing device wear and tear. The DuraHeart System carries a CE Mark and is currently available for sale outside of the United States. Additionally, the company has completed trial enrollment for this device in Japan.

The DuraHeart System features a small pump that is implanted in a pocket created in the abdomen. When the pump is activated, the impeller position is precisely controlled by the electromagnets and sensors to keep it centered within the blood chamber. Permanent magnets couple the impeller to the motor so when the motor spins, it causes the impeller to rotate and pump blood from the heart to the body. In its weakened state, the heart is not strong enough to supply sufficient blood for normal activities. The DuraHeart supplements the natural flow by pumping blood from the left ventricle to the aorta, increasing total flow to normal levels.

About Heart Failure

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 number one 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 4,000 will 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 devices. Left Ventricular Assist Systems (LVAS) are a type of mechanical circulatory device specifically designed to improve the lives of patients waiting for donor hearts, as well as those who are ineligible for a heart transplant.

About Terumo Heart, Inc.

Terumo Heart, Inc. is a U.S. subsidiary of Terumo Corporation with headquarters and manufacturing facilities in Ann Arbor, Michigan. The company's focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Terumo Corporation, 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.

SOURCE Terumo Heart Inc.

Source: PR Newswire

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