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FDA Approved Pediatric VAD

- Only FDA & CE approved Pediatric VAD

About MicroMed Cardiovascular, Inc.

In 1984, Dr. Michael DeBakey and Dr. George Noon performed heart transplant surgery on NASA-Johnson Space Center (JSC) engineer David Saucier, following a severe heart attack. Six months later, Saucier returned to JSC with the desire to apply spacecraft technology to help people with diseased hearts. As early as 1987, informal meetings began with NASA engineers and Drs. DeBakey and Noon to discuss the design of a low-cost, low-power, implantable ventricular assist device (VAD). NASA began formal funding of the development of the device four years later, bringing outer space technology to inner space applications.

In 1996, MicroMed Cardiovascular, Inc. received an exclusive license from NASA to use this rotary blood pump for cardiovascular applications. MicroMed then began the development of the critical support systems that would allow the device (system) to be approved by regulatory agencies and to be utilized in lifesaving applications in humans. European clinical trials of the MicroMed HeartAssist 5™ (the modern version of the DeBakey VAD®) began in November 1998 and CE Mark certification was awarded in April 2001 for both the Adult and Pediatric VADs. The Pediatric VAD received FDA approval under a Humanitarian Device Exemption in February 2004. The U.S. clinical study for the Adult VAD is currently underway.

MicroMed's world headquarters and its ISO 13485:2003 certified manufacturing facility is located in Houston, Texas. MicroMed has an international office located in Zurich, Switzerland.

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