- World's Smallest Heart Pump Available to Doctors and Patients
in the U.S.
- Abiomed Conference Call Scheduled for June 2, 2008 at 8:30AM
DANVERS, Mass.--(BUSINESS WIRE)--June 2, 2008--Abiomed, Inc.
(NASDAQ: ABMD) today announced it has received 510(k) clearance from
the U.S. Food and Drug Administration (FDA) for its Impella 2.5
Cardiac Assist Device. This 510(k) clearance allows Abiomed to begin
selling the device to the estimated 14,000 interventional
cardiologists at approximately 1,700 heart hospitals in the United
"FDA clearance of the Abiomed Impella 2.5 represents the next step
in enabling heart recovery for patients in the U.S. and will likely
change the standard of care in the catheterization lab," said Michael
R. Minogue, Chairman, Chief Executive Officer and President of
Abiomed. "The device seamlessly provides immediate, minimally invasive
circulatory support for critical patients."
The Impella 2.5 is inserted percutaneously in the catheterization
laboratory (cath lab) via the femoral artery into the left ventricle.
Up to 2.5 liters of blood per minute are delivered by the pump from
the left ventricle into the ascending aorta, providing the heart with
active support in critical situations.
The Impella 2.5 is cleared for use under the 510(k) for partial
circulatory support for periods up to six hours. The intra-aortic
balloon pump (IABP) also has 510(k) clearance and approximately
110,000 are used each year in the United States. Abiomed is currently
conducting two U.S. pivotal studies comparing the Impella 2.5 to the
The Impella 2.5 is now approved in more than 40 countries,
including in Europe for up to seven days of support under the CE Mark.
The Impella platform has been used to treat over 1,500 patients
outside the U.S. and has been the subject of more than 40 peer
The Company will host a conference call today, June 2, 2008, at
8:30 a.m. ET to discuss the clearance of the Impella 2.5 cardiac
assist device. Michael R. Minogue, Chairman, Chief Executive Officer
and President will host the conference call.
To listen to the call live, please tune into the webcast via
http://investor.abiomed.com or dial 866.362.5158; the international
number is 617.597.5397. The access code is 37053565. A replay of this
conference call will be available beginning at 10:30 a.m. ET on June
2, 2008 through 11:59 p.m. ET on July 2, 2008. The replay phone number
is 888.286.8010; the international number is 617.801.6888. The replay
access code is 27621107.
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.
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 and expected regulatory approvals. 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 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.
CONTACT: Abiomed, Inc.
Daniel J. Sutherby, 978-777-5410
Chief Financial Officer
For Abiomed, Inc.
Heather Nevers, 617-587-2814
SOURCE: Abiomed, Inc.