World's First Patient Supported on Abiomed's iPulse, a Combination Intra-Aortic Balloon and Ventricular Assist Device Console
Abiomed, Inc. (NASDAQ: ABMD) today announced the first patient in
Europe treated with its new intra-aortic balloon (IAB) and iPulse(TM)
Console under the recent CE Mark approval of the technology. Dr.
J.P.S. Henriques, Cardiologist at the Academic Medical Center in
Amsterdam, used the intra-aortic balloon pump during a high-risk
angioplasty procedure. Abiomed's IAB is a percutaneous 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.
"We had a positive experience with the iPulse Console and
Abiomed's intra-aortic balloon, finding the technology to be safe and
easy-to-use during a high-risk angioplasty. This new intra-aortic
balloon is a good front line treatment option to provide patients with
minimally invasive cardiac perfusion," said Dr. J.P.S. Henriques,
Cardiologist at the Academic Medical Center in Amsterdam. "We look
forward to continuing to work with Abiomed as they advance circulatory
support technologies for patients in need."
The procedure, lasting approximately an hour, provided increased
circulation during high-risk angioplasty to an 84-year-old patient
requiring stents to the left-main, the vessel that supplies blood to
the heart itself. This 8 French IAB is inserted percutaneously into a
patient's descending aorta through the femoral artery. Inflation and
deflation timing is controlled by the patient's heart rhythm or blood
pressure, to ensure maximum cardiac support.
"Approximately 160,000 intra-aortic balloons are used globally
each year. With our new IAB, Abiomed continues to make progress
expanding our global presence and product portfolio," said Michael R.
Minogue, Chairman, CEO and President of Abiomed. "Our iPulse console
and new intra-aortic balloon provide Abiomed with an earlier presence
along the continuum of patient care, allowing greater access to
potentially life-saving heart recovery technologies."
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.