First DeBakey VAD(R) Destination Therapy Patient Marks One-Year Anniversary.HOUSTON -- MicroMed Cardiovascular, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : MMCV MMCV Multi-State Minimal Cut Vector ), a leader in miniaturized implantable ventricular assist technology, announced today that the first recipient of its DeBakey VAD DeBakey VAD® Cardiology A miniaturized ventricular assist device which provides ↑ blood flow in Pts with CHF (R) (ventricular assist device ventricular assist device: see under heart, artificial. ) for Destination Therapy recently celebrated the one-year anniversary of implantation. This marks the first anniversary of the first use of an axial flow VAD (Value Added Dealer) Same as VAR. for this application in the United States. Destination Therapy refers to mechanical circulatory support for patients who are not eligible for heart transplantation Heart Transplantation Definition Heart transplantation, also called cardiac transplantation, is the replacement of a patient's diseased or injured heart with a healthy donor heart. . The patient, who was 78 at the time of the procedure, received the DeBakey VAD at California Pacific Medical Center California Pacific Medical Center (CPMC) is one of the largest private, not-for-profit, academic medical centers in Northern California. The Medical Center is a combination of three of San Francisco's oldest medical institutions: Pacific Presbyterian Hospital, Children's Hospital (CPMC CPMC California Pacific Medical Center (San Francisco) CPMC Columbia-Presbyterian Medical Center CPMC Colorado Plains Medical Center CPMC Centre Pierre et Marie Curie (French) ) in San Francisco in early November, 2004 by Dr. Soon Park, Chairman of CPMC's Department of Cardiovascular and Thoracic Surgery Thoracic Surgery Definition Thoracic surgery is the repair of organs located in the thorax, or chest. The thoracic cavity lies between the neck and the diaphragm, and contains the heart and lungs (cardiopulmonary system), the esophagus, trachea, pleura, . The patient previously had multiple heart surgeries and his condition worsened to the point where his heart was no longer able to supply enough oxygenated blood Oxygenated blood Blood carrying oxygen through the body. Mentioned in: Patent Ductus Arteriosus throughout his body to sustain his life. "We offer our congratulations to the patient, to Dr. Park and CPMC, and are pleased to see this validation of the DeBakey VAD in connection with the nation's first use of an axial flow VAD for destination therapy," commented MicroMed's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Travis E. Baugh. "We have engineered our next-generation DeBakey VAD, which has now been implanted in more than 350 patients, for the robust durability that destination therapy requires. We believe it has the potential to be well suited to serve as a long-term solution for the thousands of victims of advanced heart failure under the destination therapy indication as well as for support as a bridge to heart transplantation for the few patients who qualify for a heart transplant." "We are very pleased to have led this pioneering effort with the next-generation VAD," said Dr. Park. "The tiny device appears to provide full support but without the size and noise issues of our older devices." The miniaturized DeBakey VAD represents the next generation of implantable mechanical ventricular support for advanced heart failure. Its design addresses significant limitations of first generation systems such as weight, size, noise, reliability and high rates of infection. Its small size (approximately the size of a "C" cell battery, measuring only 1" x 3" and weighing 4 ounces) eliminates the need for abdominal surgery associated with current generation devices. The DeBakey VAD heart pump is the result of extensive research by NASA NASA: see National Aeronautics and Space Administration. NASA in full National Aeronautics and Space Administration Independent U.S. in collaboration with the Baylor College of Medicine Baylor College of Medicine is a private medical school located in Houston, Texas, USA on the grounds of the Texas Medical Center. It has been consistently rated the top medical school in Texas and among the best in the United States. and MicroMed. About our Technology MicroMed's initial platform in heart failure products is the DeBakey VAD(R) (Ventricular Assist Device) for the treatment of advanced heart failure. There are currently 15 Million victims of heart failure worldwide. With approximately 2,000 donor hearts suitable for transplantation becoming available each year in the United States or 4,000 worldwide, MicroMed believes that the DeBakey VAD can potentially be a key therapeutic option for this population. The DeBakey VAD represents a new generation of miniaturized implantable mechanical circulatory support devices. Designed in collaboration with NASA, and Drs. Michael DeBakey and George Noon with the Baylor College of Medicine, the DeBakey VAD is intended for adult and pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. advanced heart failure patients who can no longer provide necessary blood flow with their native heart. The proprietary technology is intended to take over virtually all left ventricular function and concurrently monitor real-time flow parameters. About MicroMed Cardiovascular, Inc. MicroMed currently has two ongoing clinical investigations in over thirty 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 is the only approved miniaturized implantable VAD in the US that is available for use in children. It has also been awarded the CE mark for commercial distribution in Europe. Over 350 adult and pediatric devices have been implanted worldwide for over 88 patient years of experience. MicroMed's manufacturing facility, located in Houston, Texas, is ISO (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 9001/ 13485 certified. For more information, visit www.micromedcv.com. This news release contains certain forward-looking statements pertaining to future anticipated projected plans, performance and developments, as well as other statements relating to future operations and results. Any statements in this news release that are not statements of historical fact may be considered to be forward-looking statements. Written words such as "may," "will," "expect," "believe," "anticipate," "estimate," "intends," "goal," "objective," "seek," "attempt," or variations of these or similar words, identify forward-looking statements. These statements by their nature are estimates of future results only and involve substantial risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors including, but not limited to, risks related to: our ability to obtain additional funding to support our business activities; the early-stage market for ventricular assist products and services; an expected dramatic rise in expenses; rapid growth and change in our business; as well as those risks more fully discussed in the Company's reports filed from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing its views as of any subsequent date. We do not undertake any obligation to update any forward-looking statements to reflect events or circumstances after the date of this release. |
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