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 DeBakey VAD® began in November 1998 and CE Mark Certification was awarded in April 2001 for both the Adult and Pediatric VADs. The DeBakey VAD® Child received FDA approval in February 2004.
In 2009, MicroMed made the strategic decision to address side effects encountered by existing approved devices through developing the next generation LVAD – the HeartAssist 5®. This system is the culmination of everything learned throughout the over 450 implants worldwide, together with the collaboration of countless leading experts in the Field of Mechanical Circulatory Support.
The HeartAssist 5® System received CE Mark Approval Certification in May 2009 and is currenlty being implanted in certified centers across Europe. A U.S. Clinical Trial for the HeartAssist 5® VAD System is currently underway.
MicroMed's world headquarters and its EN ISO 13485:2003/AC:2007 certified manufacturing facility is located in Houston, Texas. MicroMed has an International Office located in Uden, Netherlands.
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