Press release

Abiomed Showcases Impella® Technology that Enables Heart Recovery at ACC with 25 Presentations

DANVERS, Mass., March 05, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support and recovery technologies, announces that there are more than 25 presentations scheduled featuring Impella® heart pumps at the 67th Annual Scientific Session of the American College of Cardiology (ACC), held March 10-12, 2018, at the Orange County Convention Center in Orlando, FL.

Impella heart pumps enable treatment and heart recovery for the growing high risk population of heart failure patients with advanced coronary artery disease. Abiomed has achieved multiple FDA PMA approvals, deeming Impella heart pumps safe and effective for Protected PCI for surgically turned-down complex patients, cardiogenic shock for emergency patients and for right heart failure with the Impella RP® heart pump. Abiomed is committed to advancing the science of heart recovery through technology, innovation, education and clinical research.

The following initiatives are planned for ACC:

  • Abiomed Booth Activities
    Abiomed's booth #2635 will feature clinical data, demonstrations and opportunities for physicians to engage in hands-on simulations of the Impella platform with its augmented reality simulation tool, which allows physicians to experience the use of hemodynamic support with the Impella CP® and Impella RP® heart pumps. This is a unique training tool for insertion, placement and management of the Impella platform.
     
  • Expanded U.S. FDA PMA Indications for High Risk PCI and Cardiogenic Shock
    Abiomed will highlight two recently expanded U.S. FDA PMA labels. The first expansion is for the Impella 2.5®, Impella CP®, Impella 5.0® and Impella LD® heart pumps to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock. This approval expands the previous FDA indication for acute myocardial infarction (AMI) cardiogenic shock and post-cardiotomy cardiogenic shock (PCCS), received in April 2016. The second expansion is for the Impella 2.5® and Impella CP® heart pumps during elective and urgent high risk PCI procedures. This expanded indication confirms Impella support as appropriate in patients with severe coronary artery disease, complex anatomy and extensive comorbidities, with or without depressed ejection fraction.
  • Evening Program: The Interventional Toolbox for Complete Revascularization in Higher-Risk (and Indicated) Patients (CHIP)
    This evening program will be held on Friday, March 9 from 6:00-9:00 PM in the Hilton Orlando’s Orange Ballroom D and will highlight the latest updates on complex PCI. Presentations will address treatment of patients with complex lesions, including left main coronary artery disease, chronic total occlusions and severe calcification. During this interactive session, faculty will offer insights into selecting appropriate patients for coronary revascularization and optimizing technique. 
  • ProtectedPCI.com Digital Community
    Abiomed's digital community is the largest source of educational resources on the Impella platform of devices. Materials available include protocols and algorithms for appropriate use, summaries on the latest clinical publications and studies, case recordings and updates from ACC 2018. Learn more and sign up for updates at www.protectedpci.com.
     
  • Potential Live Cases Utilizing Impella Devices
    Abiomed anticipates the potential broadcast of several elective live cases utilizing Impella devices from participating sites during the conference. Further details regarding these live cases will be announced the day of the scheduled procedures as patient status is subject to change.

For more information about Abiomed and heart recovery, visit www.abiomed.com.

ABOUT IMPELLA HEART PUMPS

The Impella 2.5®, Impella CP®, Impella 5.0® and Impella LD® are FDA-approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. The Impella 2.5 and Impella CP devices are also approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. Abiomed's right-side heart pump, the Impella RP® device, is FDA approved to treat patients experiencing acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.

The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries.

ABOUT ABIOMED

Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com.

For further information please contact:

Ingrid Goldberg Ward
Director, Investor Relations
978-646-1590
[email protected]

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 and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, 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 most recently filed Annual Report on Form 10-K and 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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