Healthcare Industry News:  Terumo  

Devices Cardiology

 News Release - September 17, 2007

Terumo Heart Reports Summary of DuraHeart(TM) LVAS Clinical Trial Results

ANN ARBOR, Mich., Sept. 17 (HSMN NewsFeed) -- Terumo Heart, Inc. announced today that it had a successful European Launch Symposium at the European Association of Cardio-Thoracic Surgeons (EACTS) meeting in Geneva, Switzerland.

A summary of the European Clinical Trial results for the DuraHeart(TM) Left Ventricular Assist System (LVAS) was presented by Dr. Aly El-Banayosy from the Heart Center Nordrhein-Westfalen in Bad Oeynhausen, Germany, followed by 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 BioValsalva Aortic Valved Conduit developed by Vascutek Ltd, a Terumo Company.

A summary of DuraHeart LVAS clinical results to-date (as of September 15, 2007):
  • Patients enrolled = 33
  • Median age (years) = 57 (29-73)
  • Mean support duration (days) = 231194 (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 (375 196 days)
  • Kaplan Meier survival at 1 and 2 years was: 77% (all patients), 80% (<65 yrs), 90% (<60 yrs) and 100% (<50)
Chisato Nojiri, M.D., Ph.D., Chief Executive Officer for Terumo Heart, Inc., said; "We have had a number of significant milestones this year, most importantly receiving the CE Mark and a successful commercial launch in Europe."

The interest from surgeons at the EACTS has been extremely good. Dr. Nojiri commented, "We have been very pleased with the amount of interest from surgeons, both at this meeting and since receipt of the CE Mark. We are focusing significant resources on commercial activities in Europe and are looking forward to a U.S. clinical trial later this year."

The DuraHeart LVAS is a third generation circulatory support device intended to provide cardiac support for patients who are at risk of death due to end-stage left ventricular failure. It is currently the only approved implantable LVAS combining a centrifugal pump with magnetic levitation of the impeller, providing exceptional reliability and minimizing the potential for blood damage and thrombus. DuraHeart is not available in the United States.

Vascutek Deutschland GmbH, a Terumo Company, distributes DuraHeart through its Terumo Heart Division based in Hamburg, Germany. 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.


Source: Terumo Heart

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