Congestive Heart Failure

Clinical Trials Start For Ventricular Assist Device

Published in Medical Letter on the CDC and FDA, May 20th, 2001

MicroMed Technology, Inc., announced April 18, 2001, that it has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin its pivotal multi-center clinical study of the MicroMed DeBakey Ventricular Assist Device (VAD).

The clinical trial will take place at approximately 20 sites with an estimated 178 treated and control subjects.

Smaller than any other LVAD on the market, the MicroMed DeBakey VAD^R has been implanted in 85 patients to date. Measuring just 1" x 3" and weighing less than four ounces, the MicroMed DeBakey VAD is a miniaturized axial flow heart-assist pump one-tenth the size of currently...

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Source: Medical Letter on the CDC and FDA (2001-05-20)

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