Healthcare Industry News: Artificial Heart
News Release - December 18, 2006
Abiomed Announces Positive Reimbursement Recommendation at Medicare Evidence Development & Coverage Advisory Committee MeetingPanel Recommends Reimbursement Policy to Cover HDE Approved Technologies Such as the AbioCor
DANVERS, Mass.--(HSMN NewsFeed)--Abiomed, Inc. (NASDAQ: ABMD ) today announced a positive recommendation by the Medicare Evidence Development & Coverage Advisory Committee (MedCAC), formerly known as the Medicare Coverage Advisory Committee, to include Humanitarian Device Exemption (HDE) approved technologies as covered "items or services" in the Medicare clinical trial policy. CMS generally follows the recommendations of its committee and incorporates such recommendations into coverage policy. CMS plans to issue a draft of its clinical trial policy in April 2007 and a final decision is slated for July. This recommendation is a significant reimbursement milestone and could allow future coverage of Abiomed's AbioCor® Implantable Replacement Heart which was approved in September under an HDE.
"We look forward to working with the Centers for Medicare & Medicaid Services (CMS) as they assess their coverage for new, life-saving treatments like the AbioCor," said Michael R. Minogue, Chairman, CEO and President of Abiomed. "As we progress with the post-market study of the AbioCor, we hope to be able to partner with CMS and private insurers so that patients in bi-ventricular heart failure, who are not candidates for transplant, can have access to the technology."
ABOUT THE ABIOCOR
The AbioCor® Implantable Replacement Heart is one of the most sophisticated medical devices ever developed and is designed to extend the lives of patients who are not candidates for heart transplant and would otherwise die of biventricular heart failure. The AbioCor can potentially offer an improved quality of life so that a patient can be mobile and continue a productive lifestyle. The AbioCor is the only Artificial Heart without wires piercing through the skin, reducing the chance of infection. Its remote diagnostics allow patients to return home where they can resume normal activities, including bathing.
Under its HDE approval, the AbioCor will be available to a limited patient population in the United States under this approval, with no more than 4,000 patients receiving the technology each year. In order to ensure the highest standards of patient care, Abiomed intends to make the AbioCor available through a controlled roll-out at approximately five to ten heart hospitals in the United States, including qualified clinical trial sites and additional qualified centers once they have completed a comprehensive and rigorous training program. Under HDE approval, the FDA may request a panel review of the post-approval study data.
Abiomed continues to develop next-generation total Artificial Heart technology, the AbioCor II, in order to provide life-saving circulatory support to more patients in bi-ventricular heart failure. Currently in preclinical evaluation, this technology has the potential to last up to five years and is approximately 30 percent smaller than the AbioCor.
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® 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. The Company also developed the AbioCor® Implantable Replacement Heart. In Europe, Abiomed offers the minimally invasive Impella® Circulatory Support System under CE Mark approval. The Impella® 5.0 and 2.5 are investigational devices limited by Federal Law solely to investigational use in the United States. Other Impella devices are not yet available for sale in the United States. 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. 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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