- Randomized Study to Include 384 Patients At Up To 150 Sites
DANVERS, Mass.--(BUSINESS WIRE)--March 17, 2008--Abiomed, Inc.
(NASDAQ: ABMD) announced today that it has received conditional
approval from the U.S. Food and Drug Administration (FDA) to begin its
Impella(R)2.5 Circulatory Support System study in the United States
under an investigational device exemption (IDE) for hemodynamically
unstable patients undergoing a percutaneous coronary intervention
(PCI) procedure due to acute myocardial infarction (AMI), commonly
referred to as heart attack. This approval is conditional upon the
Company's submission of additional information to the FDA over the
next 45 days.
"This conditional approval for an AMI shock study represents an
exciting opportunity to provide our breakthrough Impella heart
recovery technology to a broader population of acute patients in the
catheterization lab," stated Michael R. Minogue, Chairman, President
and CEO of Abiomed. "We also continue to focus on our ongoing Impella
2.5 high-risk PCI pivotal trial and 510(k) clearance of our Impella
The AMI shock study will determine the safety and effectiveness of
the Impella 2.5 as a left ventricular assist device for heart attack
patients as compared to optimal medical management with an
Intra-Aortic Balloon Pump (IABP). According to a recent American Heart
Association report, approximately 865,000 AMI patients are treated
annually in the U.S. The study is approved under category B2 status
and the trial sites are eligible for full reimbursement from the
Centers for Medicare and Medicaid Services (CMS).
The randomized study, at up to 150 hospitals, is comprised of two
arms; those patients that receive the Impella 2.5 for up to five days
as a left ventricular assist device (VAD) and patients that receive
IABP therapy. The study will compare 192 Impella 2.5 patients to 192
IABP patients relative to a composite end point comparing safety and
efficacy. The primary endpoint will be a composite endpoint of major
events assessed at 30 days post-PCI. These major events include but
are not limited to: death, acute renal failure, and need for a major
cardiovascular operation. The secondary endpoint will be a composite
of cardiac function such as ejection fraction, requirement for
inotropic support and cardiac power output. Following Institutional
Review Board (IRB) approval at each participating hospital and
requisite training, the Company plans to ship Impella 2.5 disposables
and Impella consoles to enrolled sites.
There are estimated over 100,000 AMI anterior infarct patients
annually in the U.S. These patients suffer failure of the left
ventricle, the large main pumping muscle of the heart. Feasibility
studies show that of heart attack patients, these are the patients
that can be most helped by the Impella 2.5 technology. For Abiomed,
this translates to a potential market opportunity for the Impella 2.5
of more than $2 billion in yearly revenue for this indication alone.
In addition to this AMI study, Abiomed is currently conducting a
high-risk PCI pivotal study for its Impella 2.5 device. There are an
estimated 60,000 annual high-risk PCI patients in the U.S.
representing a potential addressable U.S. market of over $1 billion.
The Impella 2.5 is also under review by the FDA for 510(k) clearance
which, if approved, would allow Abiomed to immediately begin selling
the device to an estimated 14,000 interventional cardiologists at
1,900 hospitals in the United States.
The clinical experience to-date with Impella 2.5 has been
favorable and the technology is now approved in more than 40
countries, including Europe under the CE Mark. Impella has been the
subject of more than 40 peer reviewed publications. The Impella 2.5
device is a percutaneous device intended to provide the patients
assistance of up to 2.5 liters of blood flow per minute. It is the
world's smallest VAD and is already used outside the U.S. to treat
conditions such as AMI, cardiogenic shock, and low output syndrome.
The Impella 2.5 provides a new treatment option that aims to improve
patient outcomes through a new standard of care.
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. 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.
CONTACT: Abiomed, Inc.
Daniel J. Sutherby, 978-777-5410
Chief Financial Officer
For Abiomed, Inc.
Heather Nevers, 617-587-2814