Abiomed Announces Development of Pediatric Circulatory Support Technology.Chief Technology Officer Dr. Thorsten Siess to Present on 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. Device at the Third International Conference on Pediatric Mechanical Circulatory Support Systems and Pediatric Cardiopulmonary Perfusion DANVERS, Mass. -- Abiomed, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ABMD ABMD areal bone mineral density ABMD AEGIS Ballistic Missile Defense (US Navy) ABMD Advanced Ballistic Missile Defense ) today announced the development of a pediatric circulatory support technology. Currently in pre-clinical studies, Abiomed has developed a catheter-based heart pump, similar to the Impella LP2.5, which provides left-ventricular support to small pediatric patients requiring preconditioning prior to a cardiac intervention, or to recover patients who are either post-surgery, cannot be weaned from bypass, or who have endocarditis endocarditis (ĕn'dōkärdī`tĭs), bacterial or fungal infection of the endocardium (inner lining of the heart) that can be either acute or subacute. . The technology has been designed to operate as either a pulsatile pulsatile /pul·sa·tile/ (pul´sah-til) characterized by a rhythmic pulsation. pul·sa·tile adj. Undergoing pulsation. pulsatile characterized by a rhythmic pulsation. device that can provide up to 120 beats per minute beats per minute Cardiac pacing The unit of measure for the frequency of heart depolarizations or contractions each minute–or pulse rate or as a continuous flow technology, and is estimated to provide circulatory support for approximately two weeks. According to the American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. , approximately one percent of all newborn infants will have some type of structural heart defect. In addition, as with adults, children can experience acute (sudden) heart failure which can be caused by a virus that damages otherwise normal heart muscle or from problems with the coronary arteries, a result from birth or infection. These conditions can prevent effective blood flow to the heart muscle itself. For young patients, recovering the native heart is essential due to the lack of donor organs and also due to the effects of the necessary immunosuppression immunosuppression Suppression of immunity with drugs, usually to prevent rejection of an organ transplant. Its aim is to allow the recipient to accept the organ permanently with no unpleasant side effects. which can be challenging for these patients. "There is a clinical need to provide pediatric patients with temporary mechanical circulatory support that can be placed quickly and easily without the need for an extensive surgical procedure. Our current options for this type of support in children are limited," said Elizabeth D. Blume, M.D., Medical Director of the Heart Failure/ Transplant Program at Children's Hospital Boston Children's Hospital Boston is a children's hospital located in the Longwood Medical and Academic Area of Boston, Massachusetts. Located at 300 Longwood Avenue, Children's is adjacent both to its teaching affiliate, Harvard Medical School, and to Dana-Farber Cancer Institute. and Harvard Medical School Harvard Medical School (HMS) is one of the graduate schools of Harvard University. It is a prestigious American medical school located in the Longwood Medical Area of the Mission Hill neighborhood of Boston, Massachusetts. . "We applaud the efforts of companies like Abiomed to develop smaller pumps capable of supporting our infant and toddler, and school-age patients." "Abiomed is committed to providing patients-in-need with life-saving circulatory support technologies. The design breakthroughs developed for the Impella LP2.5 in miniaturization min·i·a·tur·ize tr.v. min·i·a·tur·ized, min·i·a·tur·iz·ing, min·i·a·tur·iz·es To plan or make on a greatly reduced scale. min and the ability to deliver high blood flows make the device well suited to provide pediatric support. I feel it is our responsibility to help answer the needs of these young patients and their parents," said Michael R. Minogue, Chairman, 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. and President of Abiomed. Abiomed's Chief Technology Officer, Dr. Thorsten Siess will present information on the new pediatric circulatory support device at the Third International Conference on Pediatric Mechanical Circulatory Support Systems and Pediatric Cardiopulmonary Perfusion being held in Hershey, Pennsylvania, from May 16-19. Dr. Siess' presentation, entitled, "Abiomed's Approach to Pediatric Heart Support with a Catheter-Based Pulsatile 12F Rotary Blood Pump," is scheduled for the session starting at 8 am ET on Saturday, May 19. The Company plans to pursue CE Mark Approval for this technology in Europe and approval by the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) under a Humanitarian Device Exemption (HDE HDE Hauptverband des Deutschen Einzelhandels (Central Association of German Retail Trade) HDE Humanitarian Device Exemption HDE Heavy-Duty Engine HDE Holdrege, Nebraska (airport code) ). ABOUT ABIOMED Based in Danvers, Massachusetts, Abiomed, Inc., is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. Abiomed currently manufactures and sells the AB5000[TM] Circulatory Support System and the BVS([R]) 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The Company also developed the AbioCor([R]) Implantable Replacement Heart. In Europe, Abiomed offers the minimally invasive Impella([R]) Circulatory Support System under CE Mark approval. The Impella([R]) 5.0 and 2.5 are investigational devices limited by Federal Law solely to investigational use in the United States. Other Impella devices, including the Impella Pediatric Pump, and the iPulse are not yet available for sale in the United States. For additional information please visit: www.abiomed.com. FORWARD-LOOKING STATEMENTS This Release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events. |
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