ANN ARBOR, Mich., March 3 /PRNewswire/ -- Terumo Heart, Inc. announced today that they have received conditional approval from the Food and Drug Administration (FDA) to begin enrollment in the US Pivotal Trial of the DuraHeart (TM) LVAS for a Bridge-to-Transplant (BTT) indication.
Dr. David Munjal, Vice President of Clinical Studies, Regulatory Affairs and Quality Systems at Terumo Heart, Inc., commented: "We are extremely pleased that FDA has allowed us to move directly to the Pivotal Trial based on our existing European data. The conditional approval was granted pending answers to some additional questions. Terumo Heart, Inc. has already responded to the FDA concerning these questions and final approval is anticipated in the near future."
Dr. Chisato Nojiri, M.D., Ph.D., Chief Executive Officer for Terumo Heart, Inc., said: "The approval of the IDE Pivotal Trial is a major milestone for Terumo Heart and we are especially pleased that the FDA has also issued approval for patients to be discharged home. This positive decision by the FDA was based on our robust preclinical data and the successful European clinical trial of the DuraHeart System."
The Pivotal Trial will be a multi-center, prospective, non-randomized study of 140 patients and will include up to 40 centers. The Principal Investigators will be Francis Pagani, M.D., Ph.D., from the University of Michigan and Yoshifumi Naka, M.D., Ph.D., from Columbia Presbyterian Hospital in New York.
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.
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.
For more information, please contact Mark White, Marketing Manager, Terumo Heart, Inc. at (734) 741-6262 or firstname.lastname@example.org.
|SOURCE Terumo Heart, Inc.|
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