Healthcare Industry News: circulatory support
News Release - February 4, 2008
Abiomed Receives Proposed National Coverage Decision from CMS for AbioCor(R) Total Replacement HeartCMS Proposes Coverage with Evidence Development (CED) Decision
DANVERS, Mass.--(HSMN NewsFeed)--Abiomed Inc. (NASDAQ: ABMD ) recently received a proposed National Coverage Decision (NCD) from the Centers for Medicare & Medicaid Services (CMS) for its AbioCor® Total Replacement Heart.
“This proposed decision is a positive development for the advancement of our AbioCor program in the United States,” said Michael R. Minogue, Chairman, President and CEO of Abiomed. “This decision by CMS provides momentum towards making the technology available for chronic patients who require bi-ventricular support and have no other treatment options.”
CMS proposed coverage with evidence development of artificial heart devices and also proposes to cover artificial heart devices in Medicare beneficiaries who are enrolled in Food and Drug Administration (FDA) approved studies. The CMS proposed decision does not guarantee Medicare coverage, but does open a public comment period for 30 days followed by CMS deliberations for a final decision to be announced no later than May 1, 2008. Three insurance companies have existing coverage policies for the AbioCor including Cigna and Humana.
In a press release issued by CMS on February 1, 2008, CMS Acting Administrator Kerry Weems stated, “Our proposal relaxes a long-standing non-coverage policy, gives access to our beneficiaries and promotes evidence development through FDA approved studies of this advanced technology.”
Under HDE approval, AbioCor has been made available to a limited patient population with no more than 4,000 patients receiving the technology in the United States each year. To date, Abiomed recently announced that it has selected four sites as AbioCor Centers including: The Johns Hopkins Hospital in Baltimore, MD; Robert Wood Johnson University Hospital in New Brunswick, NJ; Texas Heart Institute at St Luke's Episcopal Hospital in Houston, TX; and St. Vincent's Hospital in Indianapolis, IN.
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.
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 recently filed 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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