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Annals of Thoracic Surgery Publishes U.S. Registry Results for Abiomed AB5000a" Ventricular Assist Device

^{Published on 2010-09-20 06:12:01 - Market Wire}
 

DANVERS, Mass.--([ BUSINESS WIRE ])--Results from the U.S. registry of [ Abiomed, Inc. ] (NASDAQ: ABMD), AB5000 patients were recently published in the September 2010 issue of TheAnnals of Thoracic Surgery. The paper, aUse of the AB5000^TM Ventricular Assist Device in Cardiogenic Shock After Acute Myocardial Infarction (AMI),a concludes that the aresults from this nationwide registry suggest that VADs can restore normal hemodynamics and support recovery of native cardiac function in the majority of survivors when conventional therapies fail.a

"This is the largest reported paper on AMI cardiogenic shock patients on VAD support. It demonstrates that aggressive and early implantation of bridge to recovery VADs, such as the AB5000, can potentially improve recovery and survival outcomes of cardiogenic shock patients"

aThis is the largest reported paper on AMI cardiogenic shock patients on VAD support. It demonstrates that aggressive and early implantation of bridge to recovery VADs, such as the AB5000, can potentially improve recovery and survival outcomes of cardiogenic shock patients,a said Mark Anderson, MD, Robert Wood Johnson Medical School. aRecovery should be the first option. Though VAD support for AMI cardiogenic shock patients is not yet in the clinical guidelines, this paper shows that temporary heart recovery devices have the ability to recover heart muscle and avoid heart transplantation in these critically ill patients.a

This study reports on the results of the first 100 patients with AMI cardiogenic shock and implanted with the AB5000 VAD. The paper reported the following:

Results

• Fifty two percent of the 100 cardiogenic shock patients were in shock for more than 24 hours before VAD implant, the median time from shock to VAD implant was 26.5 hours and 44% of the patients underwent CPR for a mean average of 20 minutes before VAD implant. All 100 patients received high-dose inotropic support and 91% received an intra-aortic balloon before receiving VAD support.
• The estimated survival rate for AMI cardiogenic shock patients, calculated for this patient population using the Logistic EuroSCORE, is less than 15%. The actual survival rate for the same patient population in the AB5000 registry was 40%.
• Two thirds or 63% of the survivors experienced recovery of their native hearts. Recovery was defined as patients demonstrating stable unassisted cardiac function 30 days after VAD explant or at discharge.
• The survival for recovery patients at two years after VAD explant was 78% (Kaplan-Meier estimated).
• Of the survivors who stayed on AB5000 support and were not able to recover their native hearts, 80% were successfully transplanted and discharged.

aThe AB5000 is the only VAD that is designed and FDA-approved for all indications of heart muscle recovery. This paper demonstrates that heart muscle recovery is the most likely outcome for AMI cardiogenic shock survivors who have received support from a recovery VAD,a said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed. aAdditionally, the paper discusses that the use of todaya™s percutaneous VADs can help lower the threshold for VAD support in AMI cardiogenic shock patients.a

The AB5000 registry in The Annals of Thoracic Surgery can be viewed at: [ http://ats.ctsnetjournals.org/cgi/content/full/90/3/706?maxtoshow=&hits=10&RESULTFORMAT=&author1=anderson&fulltext=ab5000&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT ].

This paper can also be viewed as part of The Annals of Thoracic Surgery accredited CME program.

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 and expected regulatory approvals. 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, 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 recent 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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