Abiomed, Inc. (NASDAQ: ABMD) today announced it received the CE
Mark for its intra-aortic balloon (IAB) and iPulse(TM) console
platform. CE Mark approval allows this new combination console and
disposable balloon to be sold in all European Union countries as well
as many other countries worldwide that accept this approval for
registration. Abiomed's IAB is an easy-to-insert, minimally invasive
technology designed to enhance blood flow to the heart and other
organs for patients with diminished heart function. The iPulse
combination console platform drives Abiomed's IAB, BVS 5000 and AB5000
Circulatory Support Systems, as well as new product introductions
planned by Abiomed in the future. The iPulse is also designed to be
compatible with other Original Equipment Manufacturer's (OEMs)
balloons.
This technology is intended to provide circulatory support for
patients suffering from acute (sudden) cardiovascular failure. In many
countries outside the United States, the iPulse platform will provide
short-term and longer-term support, including bridge to transplant.
Abiomed's IAB was recently cleared by the FDA and culminates more than
two years of internal research and development. This 8 French IAB is
inserted percutaneously into a patient's descending aorta and inflates
and deflates in counterpulsation to a patient's heart rhythm.
Abiomed's new IAB was subject to extensive reliability testing and
successfully demonstrated a life of over eight million cycles, which
equates to more than 90 days of continuous operation.
"Receiving CE Mark approval for our intra-aortic balloon pump
system is a significant milestone for Abiomed," said Michael R.
Minogue, Chairman, CEO and President of Abiomed. "With this approval
we expand our presence in Europe and we will provide patients and
physicians with greater access to our extensive portfolio of
circulatory support technologies including Impella and the AB5000."
Abiomed expects to begin shipping its integrated iPulse console
outside the U.S. during fiscal fourth quarter ending March 31, 2007.
Abiomed has submitted a pre-market application (PMA) supplement for
the iPulse to the FDA. Pending regulatory approval in the U.S.,
Abiomed's initial introduction of the new iPulse to leading U.S. heart
hospitals is expected in the summer of 2007.
ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading
developer, manufacturer and marketer of medical products designed to
assist or replace the pumping function of the failing heart. Abiomed
currently manufactures and sells the AB5000(TM) Circulatory Support
System and the BVS(R) 5000 Biventricular Support System for the
temporary support of all patients with failing but potentially
recoverable hearts. The Company also developed the AbioCor(R)
Implantable Replacement Heart. In Europe, Abiomed offers the minimally
invasive Impella(R) Circulatory Support System under CE Mark approval.
The Impella(R) 5.0 and 2.5 are investigational devices limited by
Federal Law solely to investigational use in the United States. Other
Impella devices and the iPulse are not yet available for sale in the
United States. 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 Annual Report filed on Form 10-K. 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.
