Abiomed Announces AB5000(R) Portable Circulatory Support Driver
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(R) 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 iPulse(TM) 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.