MicroMed Cardiovascular, Inc. has received a CE Mark extension to continue marketing its DeBakey VAD system in Europe for another five years. The new, extended European Union CE Mark is valid until April 27, 2011.
The approval results from a rigorous scientific review of the technology and its accessories from both a design/manufacturing/quality perspective as well as a comprehensive review of all of the commercially implanted patient experience gained since the original CE Mark certification on April 27, 2001 for its approved Indications For Use.
Currently, 400 DeBakey VAD Systems have been implanted worldwide, the 400th implant having been performed just this fall by Dr. Matthias Loebe of Methodist Hospital in Houston, TX. The hospital was also the first U.S. site to implant the device.
The DeBakey VAD represents a new generation of miniaturized implantable mechanical circulatory support devices. Designed in collaboration with NASA, the Baylor College of Medicine and Drs. Michael DeBakey and George Noon, the DeBakey VAD is intended for adult and pediatric advanced heart failure patients who can no longer provide necessary blood flow with their native heart. The proprietary technology is designed to take over virtually all left ventricular function and concurrently monitor real-time flow parameters.