Healthcare Industry News: DuraHeart
News Release - April 28, 2008
Terumo Heart Summarizes Results of DuraHeart(TM) LVAS ImplantsANN ARBOR, Mich., April 28 (HSMN NewsFeed) -- Terumo Heart, Inc. announced a presentation at the recent ISHLT meeting in Boston. The presentation entitled "Long Term Circulatory Support with the DuraHeart(TM) Mag-Lev Centrifugal LVAS for Advanced Heart Failure Patients Eligible for Transplantation: European Experience" was delivered by Chisato Nojiri, M.D., Ph.D., Chief Executive Officer for Terumo Heart, Inc.
The presentation summarized results of 55 patients (33 in the CE-mark trial and 22 after market launch) who were implanted with the DuraHeart(TM) (LVAS) Left Ventricular Assist System between January 2004 and March 2008. The average duration of support was 214 +/- 226 days with a cumulative duration of 32 years. The Kaplan-Meier (K-M) survival was 82% at 6 months and 77% at 1 year. Eighteen patients (33%) were transplanted at 181 +/- 135 days. Thirteen patients (24%) were supported > 1 year with the mean support duration of 568 +/- 183 days and 2 were supported > 2 years. Twenty-seven patients (49%) remain on support for 274 +/- 276 (17-1,001) days.
K-M survival at 1 year in the CE-mark trial was 100% in patients < 50 years, 94% in those < 60 years, 80% in those < 65 years, and 67% in those greater than or equal to 65 years. Stroke free survival at 1 and 2 years in the CE-mark trial (33 patients) was 94% for the last 22 patients after implementing a less intensive anticoagulation/anti-platelet regimen. There was no pump mechanical failure, pump thrombosis, or hemolysis throughout the support duration. Dr. Chisato Nojiri commented; "We are very pleased with the long term results of the device and recently reached a major milestone with a patient reaching 1,000 days of support. This patient will reach 3 years on the device on July 4th 2008."
The presentation concluded that the DuraHeart LVAS provides safe and reliable long-term circulatory support with improved survival. High device reliability and a low stroke rate despite less intensive anticoagulation offer easier out-of-hospital management.
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 CE marked implantable LVAS combining a centrifugal pump with magnetic levitation of the impeller, providing exceptional reliability and minimizing the potential for blood damage and thrombus. The DuraHeart LVAS is not available for sale in the United States. As reported previously, Terumo Heart has received conditional approval from the FDA to commence a multicenter pivotal trial in the United States and plans to conduct the first implants at its principal investigational sites in the near future.
Terumo Heart, Inc. is a US 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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