HOUSTON, Jan. 21 /PRNewswire/ -- MicroMed Technology Inc., the world leader in miniaturized heart-pump technology for end-stage heart failure, announced today that the Food & Drug Administration (FDA) has approved MicroMed's request to supplement its IDE-approved destination therapy clinical trial. The supplement changes the patient randomization scheme to a 2:1 ratio of MicroMed DeBakey VAD(R) implants to Thoratec HeartMate XVE(R) implants.
Up to 360 patients will participate in the randomized study, with an interim patient review available once 152 patients have received the implants. The trial, known as "DELTA" (Destination Evaluation Long-Term Assist), will use the International Center for Health Outcomes and Innovation Research (InCHOIR) as its clinical data-gathering/reporting platform.
The principal investigator for the DELTA clinical trial is Dr. Eric Rose, surgeon-in-chief and chairman of the Department of Surgery at Columbia Presbyterian Medical Center in New York. "This trial offers the opportunity to study the DeBakey VAD, a state-of-the-art technology, in order to build substantially further on the clinical foundation for destination therapy that REMATCH established," Rose said.
Under the new randomization scheme, two of every three patients who participate in the trial will be implanted with the DeBakey VAD. MicroMed has reviewed this ratio of VAD usage with its 30 clinical trial sites and believes this format will allow for a more rapid demonstration of the DeBakey VAD's value in comparison to traditional devices.
"The opportunity to work with Dr. Rose and InCHOIR adds depth to our format because of their substantial experience in clinical trials involving end-stage heart failure," said Dallas Anderson, president and CEO of MicroMed. "It is also significant that the Centers for Medicare/Medicaid Services (CMS) recently increased the hospital reimbursement for the DeBakey VAD. Hospitals now can receive more than $70,000 each time they implant a DeBakey VAD."
MicroMed has implanted DeBakey VADs in more than 230 patients in the United States and around the world. MicroMed is also conducting a Bridge to Transplant pivotal clinical trial in the United States.
About MicroMed Technology Inc.
MicroMed Technology Inc. is a privately held company that develops products for patients with end-stage congestive heart failure. The MicroMed DeBakey VAD(R) was developed through collaboration with Dr. Michael DeBakey and Dr. George Noon of Baylor College of Medicine. NASA developed the mechanical and fluid dynamics capabilities in conjunction with the doctors' clinical expertise. The heart pump is only 1"x 3", weighs only 4 ounces and is silent in operation. MicroMed's manufacturing facility is ISO 9001- certified and recently passed a Food and Drug Administration GMP inspection.
The DeBakey VAD is an investigational device and is limited by federal law for investigational use in the United States.
Media Contact: Sally Ramsay
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MicroMed Technology Inc.