DANVERS, Mass., Dec 02, 2010 (BUSINESS WIRE) --
Inc. (NASDAQ: ABMD), a leading provider of breakthrough heart
support technologies, today announced it has received conditional
approval from the U.S. Food and Drug Administration (FDA) to begin
MINI-AMI, a prospective, randomized, controlled multi-site trial to
assess the potential role of the Impella(R) 2.5 in reducing infarct size
in patients with ST-elevation myocardial infarction (STEMI). The primary
objective of this study is to evaluate whether the adjunctive use of the
Impella 2.5 for 24 hours following primary percutaneous intervention
(PCI) for STEMI has the potential to limit the infarction of at-risk
myocardium compared to primary PCI with routine post-PCI care. According
to the American Heart Association (AHA), 400,000 patients in the U.S.
suffer from STEMIs every year.
"This pilot study will determine whether the Impella 2.5 can be the
first device to actually shrink infarct size," said Principle
Investigator Jeffrey Moses, M.D., New York-Presbyterian Hospital and
Columbia University Medical Center. "Today, heart attack survivors can
suffer considerable subsequent disability from damaged heart muscle. The
intent of this study is to investigate the unique unloading capabilities
of Impella 2.5 and its effect in potentially reducing infarct size and
improving quality of life for patients."
"According to the AHA, within five years after surviving your first
heart attack, 33% of men and 43% of women will die," said Michael R.
Minogue, Chairman, President and Chief Executive Officer, Abiomed. "This
will be the first Impella study to evaluate the potential therapeutic
benefits of unloading and reducing the oxygen demand on the heart
muscle. We are excited to explore more clinical benefits of Impella with
this new, hemodynamically stable patient population."
The primary endpoint of the study will be a cardiac MRI-assessed ratio
of the final infarct area to the total area of myocardium that was at
risk. This ratio will be measured at three to five days after treatment
and then again at 90 days. A total of 50 patients at five hospital sites
will be randomized to Impella 2.5 support or the institution's standard
of care with no circulatory support post-PCI. The study is based on the
hypothesis that Impella's ability to directly unload the left ventricle
will reduce overall infarct area relative to the total area at risk
which has been demonstrated in previous animal studies.
The MINI-AMI study will enroll patients with acute anterior STEMI or
large inferior STEMI, primary PCI performed within five hours of the
onset of symptoms, patients undergoing emergent primary PCI of one
culprit lesion in one major coronary vessel, and successful
revascularization of the native coronary artery at the end of PCI.
A recently published clinical study, "Prognostic Significance of the
Occurrence of Acute Heart Failure After Successful Primary Percutaneous
Coronary Intervention" by L. Savic, et al., published in the Journal
of Invasive Cardiology, studied 1,074 consecutive STEMI patients who
had no signs of heart failure at admission, were not in cardiogenic
shock at admission and were treated with successful PCI. This study
serves as a reference for the MINI-AMI patient population and
demonstrated the following:
Acute heart failure (AHF) during hospitalization occurred in 11.1% of
patients in this study;
81.8% of these AHF patients died in the first 30 days;
In some patients, even timely and successful PCI cannot prevent
extensive myocardial damage;
Patients who developed AHF had a lower ejection fraction;
There was no significant difference between groups regarding the
duration of symptoms or door-to-needle time.
The study concluded that even after successful PCI, the occurrence of
AHF during hospitalization remains an independent predictor of 30-day
and one year mortality. Additionally, the study noted that further
investigation is needed to evaluate whether modification of
post-procedural treatment can reduce the incidence of AHF.
1. Meyns, et al. Left ventricular support by Catheter-Mounted axial flow
pump reduces infarct size. JACC, 2003.
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,
including 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 most
recently filed Quarterly Report on 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.
SOURCE: Abiomed, Inc.
Aimee Maillett, 978-646-1553
Public Relations Specialist