ABIOMED Announces Favorable High-Risk PCI Data on IMPELLA RECOVER LP 2.5 Published in American Journal of Cardiology.DANVERS, Mass. -- Safety and Feasibility of World's Smallest Micro-Ventricular Assist Device Shown in Cath-Lab Setting for High-Risk, Minimally Invasive Procedures 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 peer-reviewed data on the IMPELLA(R) RECOVER(R) LP 2.5 in the April issue of the American Journal of Cardiology (Volume 97, Issue 7). The study by Dr. J.P.S. Henriques, Cardiologist at the Academic Medical Center in Amsterdam, included 19 patients with high-risk Percutaneous Coronary Interventions (PCI (1) (Payment Card Industry) See PCI DSS. (2) (Peripheral Component Interconnect) The most widely used I/O bus (peripheral bus). ) and who were poor candidates for surgery. This article entitled, "Safety and Feasibility of Elective High-Percutaneous Coronary Intervention Procedures with Left Ventricular Support of the IMPELLA RECOVER LP 2.5," found: --The device successfully supported 100% of patients undergoing elective high- risk PCI procedures --There were no significant device-related adverse events --No aortic valve regurgitation regurgitation /re·gur·gi·ta·tion/ (re-ger?ji-ta´shun) 1. flow in the opposite direction from normal. 2. vomiting. during device operation --There were no strokes --There was no limb pain or ischemia --No post procedure complications "Our experience with the IMPELLA RECOVER LP 2.5 has been quite positive. The device has proven to be safe and I am pleased with its ease-of-use and ability to provide both hemodynamic he·mo·dy·nam·ics n. (used with a sing. verb) The study of the forces involved in the circulation of blood. he support and improved, sustained coronary circulation in the cath-lab. We found the device to be effective in this patient group and we look forward to using this technology for other applications in our cath-lab, such as for patients presenting acute myocardial infarction acute myocardial infarction ( PCIs encompass a variety of procedures that take place in the catheterization catheterization Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages. lab to treat occluded or narrowed vessels that supply blood to the heart. Historically, intra-aortic balloon pump intra-aortic balloon pump n. A pump connected to a balloon device that is inserted into the descending aorta to provide temporary assistance to the heart in the management of left ventricular failure. (IABP IABP intra-aortic balloon pump. ) counterpulsation has been used extensively to support patients that are at high risk for mortality and morbidity when undergoing these PCI procedures. However, because IABP does not actively unload the heart, it requires a minimum of cardiac function to be effective. It also requires a stable cardiac rhythm. In the case of blood pressure collapse during high-risk PCI, for example, IABP support is unlikely to reverse shock and restore normal hemodynamics hemodynamics /he·mo·dy·nam·ics/ (-di-nam´iks) the study of the movements of blood and of the forces concerned.hemodynam´ic he·mo·dy·nam·ics n. . IMPELLA RECOVER LP 2.5 actively unloads the heart and, therefore, better serves these patients in the event of major procedural complications, such as abrupt vessel occlusion or blood pressure collapse. The IMPELLA RECOVER LP (Left Percutaneous) 2.5 can deliver in excess of 2.5 liters of blood per minute and actively unloads the ventricle ventricle /ven·tri·cle/ (ven´tri-k'l) a small cavity or chamber, as in the brain or heart.ventric´ular ventricle of Arantius the rhomboid fossa, especially its lower end. , increasing the cardiac output and both coronary and end-organ perfusion. It is minimally invasive and can be inserted into the left ventricle in a catheterization lab via a standard guidewire through the femoral artery. The IMPELLA RECOVER technology is CE marked in Europe and has been used in European centers to support more than 500 patients during high-risk percutaneous coronary intervention (PCI), post-PCI, Acute Myocardial Infarction (AMI or heart attack) and patients with compromised hemodynamics. This device provides cardiologists with the first technology designed to effectively support patients in the cath-lab, during minimally invasive yet high-risk procedures, such as high-risk stent placement. "The positive results of this study reflect the success and performance we have demonstrated with our IMPELLA RECOVER 2.5 in Europe and it provides cardiologists with key data supporting the benefits of using IMPELLA for minimally invasive circulatory support," 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. "We see a strong global need for this technology with particularly high demand in the United States." The American Journal of Cardiology (R) is an independent journal designed for cardiovascular disease specialists and internists with a subspecialty subspecialty, n a limited portion of a narrowly defined professional discipline. E.g., surgery is a specialty of medicine and pediatric vascular surgery is a subspecialty. in cardiology throughout the world. AJC AJC Atlanta Journal & Constitution AJC American Jewish Committee AJC Arabian Jockey Club AJC American Jewish Congress AJC Australian Jockey Club (Sydney, Australia) AJC Anderson Junior College (Singapore) is an independent, scientific, peer-reviewed journal of original articles. ABOUT THE IMPELLA(R) RECOVER(R) LP 2.5 The RECOVER LP 2.5 is a minimally invasive ventricular unloading catheter, which is inserted percutaneously via the femoral artery into the left ventricle. Up to 2.5 liters of blood per minute are delivered by the pump from the left ventricle into the ascending aorta, providing the heart with active support in critical situations. A large percentage of patients with acute myocardial infarction require such temporary mechanical support in order to survive. The RECOVER LP 2.5 can be inserted quickly and provides efficient cardiovascular support. The RECOVER LP 2.5 can be implanted for up to five days. IMPELLA products are investigational devices limited by Federal Law solely to investigational use in the United States and are not yet available for sale in the United States. 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 BVS Biblioteca Virtual em Saúde (Brazil) BVS Bureau of Vital Statistics BVS Brethren Volunteer Service (Church of the Brethren) BVS Boston Vegetarian Society (Cambridge, MA) (R) 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. In Europe, ABIOMED offers the IMPELLA(R) RECOVER(R) minimally invasive cardiovascular support systems under CE Mark approval. The Company's AbioCor(R) Implantable Replacement Heart was the subject of an initial clinical trial under an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. 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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