DANVERS, Mass.--([ BUSINESS WIRE ])--[ Abiomed Inc ]. (NASDAQ: ABMD), a leading provider of [ breakthrough heart support technologies ], today announced Symphonya", a new synchronized minimally invasive implantable cardiac assist device, designed to treat chronic patients with moderate heart failure by improving patient hemodynamics, and potentially improving quality of life. The device is designed with the primary goal of stabilizing the progression of heart failure and/or recovering/remodeling the heart. Prior to this, no current implantable cardiac assist device had been designed for heart recovery or remodeling.
The small, minimally invasive device is remotely implanted and requires a simple apacemakera pocket insertion, avoiding a sternotomy. It is designed to recover and/or remodel the patientas heart muscle with the intent to explant the device after extended support at home. Symphony is designed to offer the following potential benefits for heart failure patients:
- Cost-effective solution to improve patient hemodynamics
- Alleviate heart failure and angina symptoms
- Preserve end-organ function
Symphonyas simple design enables physicians to implant the device with a single graft to the subclavian artery remotely from the heart. A small pocket under the skin to hold the device is made using the same incision. The Symphony is synchronized to the heart through subcutaneous electrocardiogram leads and provides an output of 3.0 L/min at 100 beats per minute and is designed to potentially:
- Reduce the afterload, decreasing the work of the left ventricle
- Increase the cardiac output and mean arterial pressure
- Increase the coronary and systemic blood flow
Symphony is designed to be a cost-effective alternative for New York Heart Association (NYHA) Class III patients who are not amenable to revascularization, do not respond to inotropes and/or cardiac resynchronization therapies (CRT), and continue to experience poor quality of life with frequent hospital admissions. Additionally, these patients maintain all future options such as medications, adjunctive therapies (pharma, stem cell) as well as heart transplantation or implantable left ventricular assist devices (LVADs).
Symphonyas simple design will provide a lower price point than conventional implantable LVADs. The minimally invasive implantation should lead to a shorter length of stay before the patient is discharged home.
The product has been under development for several years and has solid patent coverage. The product was unveiled today in a presentation made by Robert Dowling, M.D., at the American Heart Association (AHA) 2011 Scientific Sessions in Orlando, Florida. The first-in-man procedure is expected early next year outside of the United States. For more information on Symphony and to view the AHA 2011 slide presentation, visit [ www.abiomed.com ].
The company will discuss more details on the Symphony specifications and timeline at the Investor Day on December 9, 2011, in New York.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. 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 and most recently filed Quarterly Report on Form 10-Q. 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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