Abiomed, Inc. (NASDAQ: ABMD) today announced it completed the CE
Mark for its Portable Circulatory Support Driver. CE Mark approval
allows this new Portable Driver to be sold in all European Union
countries as well as many other countries worldwide that accept this
approval for registration. The Portable Driver is designed to support
Abiomed´s AB5000(TM) Ventricular Assist Device (VAD) for both
in-hospital and out-of-hospital patients.
The new AB5000 Portable Driver is lightweight, quiet, demonstrates
reliable performance, and has the potential to improve patient care
while lowering costs to hospitals. The AB5000 Portable Driver provides
patients requiring VAD support a greater degree of mobility and
improved quality of life during treatment aimed at myocardial
recovery. The BVS and AB5000 have exclusive U.S. approvals for all
heart recovery indications, and have collectively supported more than
10,000 patients worldwide.
Abiomed´s AB5000 Portable Driver, at only 18 pounds, is the
lightest and most powerful bi-ventricular system in the industry. It
delivers the pressures and vacuums equivalent to Abiomed´s AB5000
console and its recently approved iPulse(TM) combination console.
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 or more.
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. Abiomed recently announced FDA labeling
approval of one year bench reliability for its AB5000 VAD, which is
expected to complement the Portable Driver reliability.
"There is a clinical and financial demand for a highly reliable
mobile driver that allows for patient discharge. We are now offering
each heart hospital a complete portfolio of circulatory care products
that help the heart recover, from the cath lab to the surgery suite to
the I.C.U. to home discharge," said Michael R. Minogue, Chairman, CEO
and President of Abiomed.
The AB5000 VAD is approved in Europe under CE-mark and has
supported patients for up to 312 days. 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.
Abiomed´s Portable Driver has not been approved by the U.S. Food
and Drug Administration (FDA). The Company is pursing an
investigational device exemption (IDE) to conduct a discharge study,
which was submitted in January 2008 for FDA review. The Company is
currently working to resolve open issues and questions from their
response. As proposed, the U.S. study would target 20 transplant
hospitals for 30 patients.
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 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.
