MicroMed Cardiovascular, Inc. currently has two ongoing clinical investigations in leading US heart transplant centers to evaluate the safety and effectiveness of the DeBakey VAD for use as a Bridge to Heart Transplantation and for Destination Therapy for patients ineligible for heart transplant. The DeBakey VAD system has been awarded the CE mark for Bridge to Transplant and Destination Therapy for commercial distribution in Europe. The DeBakey VAD Child, the only approved miniaturized implantable VAD in the US, is available for use in children. It has also been awarded the CE mark for commercial distribution in Europe. Over 380 adult and pediatric devices have been implanted worldwide for almost 100 patient years of experience. MicroMed's manufacturing facility, located in Houston, Texas, is ISO 9001/13485 certified.