Abiomed, Inc. (NASDAQ: ABMD) today announced that it has developed a new Portable Circulatory Support Driver for both in-hospital and out-of-hospital patients. The Portable Driver is designed to support Abiomed’s AB5000® Ventricular Assist Device (VAD).
The combination of Abiomed’s new Portable Driver and its FDA-approved AB5000 VAD provides support of acute heart failure patients. In many cases, profound shock patients require biventricular support (both sides of the heart). The AB5000 can assume the pumping function of a patient’s failing heart, allowing the heart to rest, heal and potentially recover. AB5000 is designed to provide either uni-ventricular or bi-ventricular support. Abiomed also announced today that it has received FDA labeling approval of one year bench reliability for its AB5000 VAD, which is expected to complement the Portable Driver reliability.
“My experience with the AB5000 Circulatory Support System has been excellent in treating over 30 patients with support duration of up to 40 days,” said Louis Samuels, M.D., FACS Surgical Director Heart Failure and Transplant, Director Artificial Heart & Ventricular Assist Device Program, Lankenau Hospital. “The new Portable Driver is lightweight and quiet, demonstrates reliable performance, and has the potential to improve patient care while lowering costs to hospitals.”
"There is a clinical need to provide patients requiring VAD support a greater degree of mobility during treatment aimed at myocardial recovery,” said John V. Conte, M.D., Associate Director of Cardiac Surgery, Associate Professor of Surgery, Director of the Heart and Lung Transplantation, Director of the Ventricular Assist Device Program, Johns Hopkins Hospital. “The expected durability of this portable driver is a nice match with the AB5000 VAD and could provide an integrated and effective solution for patients requiring uni-ventricular or bi-ventricular support.”
Abiomed’s Portable Driver is a powerful bi-ventricular system which delivers the pressures and vacuums equivalent to Abiomed’s AB5000 console and its recently approved iPulseTM console, at only 18 pounds in weight. Internal testing of the Portable Driver and the AB5000 Ventricle has demonstrated high reliability. This testing showed that the Portable Driver is capable of providing full support for a year’s intended use. The unit is expected to require low maintenance, approximately every 5,000 hours of operation, which is estimated to be three times longer than existing portable consoles that weigh twice as much. Abiomed’s Portable Driver was designed with the latest smart battery technology for extended power capability and the quiet operation of the Portable Driver provides for minimal disruption of the patient’s quality of life at-home or while in care centers.
In addition to providing an advanced clinical option for heart centers, Abiomed’s Portable Driver is expected to be cost-effective for hospitals. Procedures are supported with associated in-hospital Medicare reimbursement that range from approximately $80,000 to $171,000 per patient stay, with the additional potential for direct console cost reimbursement per patient discharged.
Abiomed’s Portable Driver has not yet been approved by the U.S. Food and Drug Administration (FDA). The Company plans to pursue an investigational device exemption (IDE) to conduct a discharge study, which is expected to be submitted in early calendar 2008. Daniel Goldstein, M.D., Associate Professor, Department of Cardiothoracic Surgery, Albert Einstein College of Medicine, Director, Cardiac Transplantation and Mechanical Assistance Programs, Co-Director, Center for Advanced Cardiac Therapy, Montefiore Medical Center, is the principal investigator for the study. “I am excited to begin this study as this new device shows the potential to provide an additional alternative for heart failure patients to improve their quality of life while we focus on heart recovery,” said Dr. Goldstein.
The AB5000 VAD is also approved in Europe under CE-mark and has supported patients for up to 312 days. Abiomed expects to start supporting patients with the Portable Driver in Europe in its fiscal fourth quarter ended March 31, 2008 with CE-mark approval. Outside of the U.S., the AB5000 is used as a bridge-to-recovery (BTR) and bridge-to-transplant (BTT) device, and the Portable Driver is expected to greatly enhance the Company’s BTT market opportunity.
“The physicians still treat many bi-ventricular patients and want the flexibility to discharge,” said Michael R. Minogue, Chairman, CEO and President of Abiomed. “From a business perspective, we believe the Portable Driver will increase the utilization of our AB5000 disposables at heart centers globally.”
Abiomed’s AB5000 has FDA approvals for all acute heart failure indications. The current installed base of Abiomed's AB5000 Circulatory Support System, prior to the announcement of this Portable Driver and Abiomed’s iPulse combination console, is comprised of greater than 50% of the 119 U.S. transplant hospitals and greater than 22% of the 866 U.S. open heart hospitals.
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. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including the Company's ability to provide the FDA with the additional information it has requested, the results of the Company's pivotal study, 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 risk factors contained in the Company’s 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.
Contacts:
Daniel J. Sutherby, 978-777-5410
Chief Financial
Officer
ir@abiomed.com
or
For
Abiomed, Inc.
Brodeur
Heather Nevers, 617-587-2814
Media
Relations
hnevers@brodeur.com
