Terumo Heart, Inc. has announced that DuraHeart 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. The conclusions published are based on the European experience with DuraHeart, the first active magnetically levitated centrifugal left ventricular assist system. 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. 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.