MicroMed gets conditional approval from FDA to begin multi-center trial of DeBakey VAD.MicroMed Technology, Inc., Houston, TX announced it has received conditional approval from the US Food and Drug Administration (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. ) to begin its pivotal multi-center clinical study of the MicroMed DeBakey Ventricular Assist Device ventricular assist device: see under heart, artificial. (VAD (Value Added Dealer) Same as VAR. ). The company says the Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the will take place at approximately20 sites with an estimated 178 treated and control subjects. The company reports the MicroMed DeBakey VAD is smaller than any other LVAD LVAD left ventricular assist device; see ventricular assist device, under device. currently on the market and has been implanted in 85 patients to date. The device measures just 1" by 3" and weighs less than 4 ounces, which is 1/10 the size of currently marketed VADs. MicroMed says its small size makes the implantation surgery less invasive, reduces operating time, tissue disruption is minimized, and is expected to have lower incience of infection and perioperative bleeding. The trial represents an extension of the feasibility trial, which began in June 2000 at the Methodist Hospital in Houston. The MicroMed Debakey VAD is an investigational device and is limited by federal law for investigational use in the US. Contact: Megan Taylor - (310) 577-7870, ext. 165 |
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