Study Data Show Positive European Experience With DuraHeart Left Ventricular Assist Device for Advanced Stage Heart Failure Patients

ANN ARBOR, Michigan - Sustained Benefits for Patients Awaiting Transplantation

The DuraHeart(TM) Left Ventricular Assist System (LVAS) shows sustained benefits in providing safe and reliable long-term circulatory support with an improved survival rate and an acceptable adverse event rate in advanced heart failure patients who were eligible for transplantation. These conclusions, based on the European experience with DuraHeart, the first active magnetically levitated centrifugal left ventricular assist system, are published on line in the European Journal of Cardio-thoracic Surgery (EJCTS) at dx.doi.org/10.1016/j.ejcts.2008.12.033.

The European experience includes 68 patients who received the DuraHeart Left Ventricular Assist System between January 2004 and July 2008 including 33 patients treated as part of the European multi-center clinical trial (Germany, Austria, and France) and 35 patients treated in the post-trial period. All patients were classified with end-stage heart failure and were on approved lists to receive donor hearts (Bridge to Transplant). The trial sponsor was Terumo Heart, Inc., maker of the DuraHeart System and a wholly owned subsidiary of Terumo Corporation.

“In a patient population with advanced disease at imminent risk of death due to end-stage left ventricular failure and eligible for heart transplantation, the DuraHeart was safe and performed as intended,” said Michiel Morshuis, M.D. Senior Physician, Clinic for Thoracic and Cardiovascular Surgery at the Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen. “We believe the device may have potential for long-term circulatory support not only as a bridge to transplant, but also for destination therapy.”

Overall, the mean support duration for this study population was 242 days plus or minus 243 days (range: 19 - 1148, median: 161) with a cumulative duration of 45 years. As of the publication date, 35 patients (51 percent) remained in ongoing treatment with DuraHeart, 18 patients were transplanted, one device was explanted and 14 patients died during support with a median time to death of 62 days. The Kaplan-Meier survival rate during support for the 68 patients in the clinical trial and post-trial period was 81 percent at six months and 77 percent at one year.

Of the 13 patients (21 percent) supported for >1 year, four supported for > two years, one supported > three years, two transplanted, two died, and nine ongoing with a mean duration of 744 plus or minus 216 days (range: 537 - 1,148, median: 651). There were no reports of device thrombosis, hemolysis, peripheral thromboembolic events, myocardial infarction or chronic renal dysfunction.

The total major adverse event rates during DuraHeart support were acceptable in comparison to first generation pulsatile and second generation axial flow LVADs. The event rate of bleeding requiring surgery (0.22 per patient-year) was considerably lower for the third-generation DuraHeart when compared with the rate for first- and second-generation LVADs (1.47 and 0.78, respectively). Additionally, driveline or pocket infection rate was reduced by 90 percent as compared to the pulsatile device (0.40 vs. 3.49) and comparable to the small axial flow devices (0.40 and 0.37).

The rate of neurological events for 33 trial patients was 50 percent less than that of pulsatile devices (0.56 vs. 1.11) and slightly higher than the rate in the axial flow device group (0.56 vs. 0.45). The most significant number of adverse events, including fatal intra-cerebral bleeding (75 percent) and other bleeding complications was observed in the first 11 patients. The investigators recognized that the risk of bleeding complication rose with age, with a likely cause being excessive anticoagulation/anti-platelet regimen. The investigators agreed to follow a less intensive aniticoagulation/anti-platelet regimen, which resulted in significantly improved results (neurological dysfunction: 0.23 per patient-year with no incident of CVA (Cerebrovascular Accident)) for the remainder of the study.

“Our European experience paved the way for our U.S. clinical trial, serving as a highly positive and important beginning to our plans for a broader global introduction of this much-needed technology,” said Chisato Nojiri, M.D., Ph.D., Chairperson of the Board & Chief Medical Officer for Terumo Heart. “We have invested significant resources to ensure the design, quality, manufacturing, and critical scientific evidence behind DuraHeart. We greatly appreciate the confidence and support we have from physicians in Europe and in our clinical trials to entrust their patients to DuraHeart.”

About the DuraHeart System

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. The pivotal U.S. Bridget to Transplant DuraHeart Trial, involving up to 40 clinical sites and 140 patients is in process. 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. For more information, visit www.terumoheart.com.

Source: Terumo Heart, Inc.

Martin Schildhouse, +1-305-606-3577 or Robert J. Murphy, +1-908-276-0777, both of The Storch-Murphy Group, Ltd.