FDA approves MicroMed request to supplement its IDE-approved destination therapy trial.MicroMed Technology, Inc., Houston, TX, announced that the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. has approved the company's request to supplement its IDE (investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and )-approved destination therapy clinical trial. The supplement changes the patient randomization randomization (ranˈ·d  ·m scheme to a 2:1
ratio of MicroMed DeBakey VAD DeBakey VAD® Cardiology A miniaturized ventricular assist device which provides ↑ blood flow in Pts with CHF implants to Thoratec HeartMate XVE
implants.
The company says up to 360 patients will participate in the randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. 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 (InCHOIR) as its clinical data-gathering/reporting platform. Under the new randomization scheme, 2 of every 3 patients who participate in the trial will be implanted with the DeBakey VAD. The company believes the new format will allow for a more rapid demonstration of the DeBakey VAD's value in comparison to traditional devices. Contact: Sally Ramsay - (713) 627-2223, ext. 102 |
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