HOUSTON, Nov. 13 /PRNewswire/ -- MicroMed Technology, Inc., global leader in miniaturized heart pump technology, announced today that it has received Food & Drug Administration (FDA) approval to conduct its multi-center clinical trial destination therapy in up to 40 centers in the United States.
A pilot study of 30 patients has already been completed and submitted to the FDA. The pivotal study is a randomized trial design, using Thoratec's HeartMate XVE(R) as the control. The "destination therapy" patient population in the United States exceeds 50,000 people who are ineligible for a heart transplant. The trial will include approximately 300 patients. Most of the trials will occur at Center for Medicare/Medicaid Services (CMS) approved sites.
Designed in collaboration with NASA, the Baylor College of Medicine and Drs. Michael DeBakey and George Noon for long-term use, the DeBakey VAD is intended for end-stage heart failure patients who can no longer provide necessary blood flow with their native heart. MicroMed is also conducting a multi-center pivotal trial for VAD use as a Bridge-to-Transplant at 20 clinical sites across the U.S. "These world-renowned transplant centers provide unparalleled experience in mechanical circulatory support and are already familiar with our DeBakey VAD technology," said Betty Russell- Silverstein, executive vice president for MicroMed. "Many have a keen interest in leading the new generation of miniaturized VADs for the future."
The DeBakey VAD system has been awarded the CE mark for commercial distribution in Europe, with over 220 VADs implanted worldwide. The device is the size of a "C" cell battery, is silent, and weighs less than four ounces. "This is an excellent opportunity to evaluate the miniaturized DeBakey VAD against the HeartMate XVE of REMATCH," said Dallas Anderson, president and CEO of MicroMed. "We believe that the size, silence and significant weight reduction will be a major positive quality of life issue for these long term patients."
MicroMed Technology, Inc. is a privately held company that develops products for patients with end-stage, congestive heart failure (CHF). MicroMed recently passed an FDA GMP inspection in anticipation of its approval for DeBakey VAD pediatric manufacture and use. MicroMed's headquarters and ISO 9001 certified Class 10,000 clean room manufacturing facility is located in Houston, Texas. For more information, visit http://www.micromedtech.com/ .
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MicroMed Technology, Inc.
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