Healthcare Industry News:  ventricular assist device 

Devices FDA Cardiology

 News Release - March 30, 2009

FDA Approves Abiomed's New AB Portable Driver; Providing Patient Transport, Mobility and Ambulation without Compromising Performance

Quiet, Lightweight, Compact Driver Delivers Intuitive, Integrated Solution

DANVERS, Mass.--(HSMN NewsFeed)--Abiomed, Inc. (NASDAQ: ABMD ), a leading provider of heart recovery products designed to recover hearts and eliminate in-hospital deaths from heart attacks and high risk percutaneous coronary interventions (PCI), today announced U.S. Food and Drug Administration (FDA) approval of its Premarket Approval Application (PMA) supplement for the AB Portable™ driver. The FDA PMA approval permits the AB Portable driver to facilitate intra-facility patient transport, patient mobility for participation in physical and rehabilitation therapies, independent ambulation by the patient, and inter-hospital transport via aircraft or ambulance.

The new AB Portable driver offers a reliable cardiovascular support system, providing full Bi-ventricular assist device (Bi-VAD) functionality. The new driver is designed to enhance the clinical utility of the Abiomed AB5000™ Ventricle by delivering direct benefits to both the hospital staff and patients by increasing mobility and versatility without compromising performance, specifically:

  • The powerful, self-contained driver assists the sickest patients, offering hemodynamic support directly from the operating room up through the weaning process without additional computers or docking stations, which are required with current portable consoles.
  • The AB Portable driver maintains Abiomed’s standard for quality and reliability by requiring low-maintenance intervals of approximately every 5,000 hours or up to seven months of operation, which is estimated to be three times longer than existing portable consoles.

“Patients on full BiVAD support for heart recovery often require mobility and transport in order to provide a comprehensive assessment for a next stage of therapy,” said Mark Anderson, M.D., Department of Cardiothoracic Surgery, Robert Wood Johnson University Hospital. “The AB Portable driver is lightweight and compact and the quietest portable Bi-VAD console on the market, yet still provides that full level of Bi-VAD support from the minute you leave the surgery suite.”

The new AB Portable driver also offers a patient-centric design including the following features:

  • A compact architecture that enables easy handling and transport. The driver is 25 percent smaller and 15 percent lighter than current portable consoles on the market, allowing easier independent patient ambulation, in-hospital transfer or land/air transportation.
  • Quiet operation with minimal disruption to the patient and their environment. The Portable driver is 50 percent quieter than current portable consoles on the market, maintaining a more unobtrusive operation and providing minimal distractions for patients and care-givers.
  • An advanced power system that offers smart battery management. The driver can operate up to 10 hours without recharging and includes an integrated battery-gauge display that offers the user real-time battery status displayed in hours and minutes. The AB Portable driver is the only US approved portable console to provide this essential feature.

“The new AB Portable driver platform further strengthens Abiomed’s portfolio for treating acute heart failure patients with profound cardiogenic shock, while allowing a greater degree of mobility and instant VAD support for the patient immediately after the procedure,” said Michael R. Minogue, Chairman, President and Chief Executive Officer of Abiomed.

Separate from the PMA supplement, Abiomed received conditional IDE approval from the U.S. Food and Drug Administration (FDA) in May 2008 to conduct a U.S. patient discharge study with the AB Portable Driver at 20 hospitals for 30 patients. The VOYAGER I clinical study aims to evaluate the safety and performance of the AB Portable Driver System in combination with the AB5000 Ventricle in the outpatient environment. Of the eighteen U.S. hospital sites that have submitted for IRB review, eight hospitals have received IRB approval and are open for enrollment in the VOYAGER I trial.

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 and related regulatory approvals, the outcome of the VOYAGER I clinical study, 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.


Source: Abiomed

Issuer of this News Release is solely responsible for its content.
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