Terumo Heart Reports Summary of DuraHeart(TM) LVAS Clinical Trial Results
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A summary of the European Clinical Trial results for the DuraHeart(TM)Left Ventricular Assist System (LVAS) was presented by Dr. Aly El-Banayosyfrom the Heart Center Nordrhein-Westfalen in Bad Oeynhausen, Germany, followedby the presentation "The Emerging New Era of Mechanical Circulatory Support,"by Dr. Eric Rose of Columbia University Medical Center in New York.
The symposium highlighted the DuraHeart device, as well as the BioValsalvaAortic Valved Conduit developed by Vascutek Ltd, a Terumo Company.
A summary of DuraHeart LVAS clinical results to-date (as of September 15,2007):
Chisato Nojiri, M.D., Ph.D., Chief Executive Officer for Terumo Heart,Inc., said; "We have had a number of significant milestones this year, mostimportantly receiving the CE Mark and a successful commercial launch inEurope."
The interest from surgeons at the EACTS has been extremely good. Dr.Nojiri commented, "We have been very pleased with the amount of interest fromsurgeons, both at this meeting and since receipt of the CE Mark. We arefocusing significant resources on commercial activities in Europe and arelooking forward to a U.S. clinical trial later this year."
The DuraHeart LVAS is a third generation circulatory support deviceintended to provide cardiac support for patients who are at risk of death dueto end-stage left ventricular failure. It is currently the only approvedimplantable LVAS combining a centrifugal pump with magnetic levitation of theimpeller, providing exceptional reliability and minimizing the potential forblood damage and thrombus. DuraHeart is not available in the United States.
Vascutek Deutschland GmbH, a Terumo Company, distributes DuraHeart throughits Terumo Heart Division based in Hamburg, Germany. Terumo Heart, Inc. is aU.S. subsidiary of Terumo Corporation with headquarters and manufacturingfacilities in Ann Arbor, Michigan. The company's focus is the innovation andintroduction of products to improve the quality of healthcare for heartfailure patients. Terumo Corporation, located in Tokyo, Japan, is a leading
developer, manufacturer and global marketer of a wide array of medicalproducts.* Patients enrolled = 33 * Median age (years) = 57 (29-73) * Mean support duration (days) = 231ą194 (range: 17-803) * Cumulative support duration = 7610 days (> 20 years) * 7 patients (21%) supported > 1 year, and one supported > 2 years. * 12 patients (36%) remain on support with a mean duration > 1 year (375ą 196 days) * Kaplan Meier survival at 1 and 2 years was: 77% (all patients), 80% (<65 yrs), 90% (<60 yrs) and 100% (<50)
SOURCE Terumo Heart, Inc.
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