MicroMed Technology gets FDA nod to expand VAD feasibility study to 3 sites

Transplant News, Jan 31, 2001

MicroMed Technology, Inc., Houston, TX, announced it has received FDA approval to expand the US MicroMed DeBakey Ventricular Assist Device (VAD) feasibility study from its initial site at The Methodist Hospital in Houston, TX to 3 sites and 20 patients. To date 6 patients have been implanted with the device at Methodist Hospital.

The company says that following internal approval, the additional sites are expected to begin implantation early this year. MicroMed expects the expanded study will provide enough information to begin a FDA-approved multi-center pivotal study, eventually leading to FDA approval to market the device.

The device measures 1" by 3" and weighs less than 4 ounces, considerably smaller and less invasive that with the larger LVAD's, the company notes. This results in reduced operating time, tissue disruption, risk of infection and perioperative bleeding. The device was developed with the support of Michael DeBakey, MD, Baylor College of Medicine Chancellor Emeritus, George Noon, Baylor Professor of Surgery, and engineers at the National Aeronautics Space Administration (NASA).

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