European Registry Results Highlight Impella's Role in Left Ventricular Support for High-Risk PCI ProceduresDANVERS, Mass., Dec 17, 2009 (BUSINESS WIRE) -- Results from the Europella registry, evaluating the safety and
feasibility of the Abiomed,
Inc. (NASDAQ: ABMD) Impella
2.5 circulatory assist device in high-risk percutaneous coronary
intervention (PCI) procedures have been published in the December 15
issue of the Journal of the American College of Cardiology (JACC). The
paper, "Supported High-Risk Percutaneous Coronary Intervention Using the
Impella 2.5 device: The Europella Registry" concludes, "this large
multicenter registry supports the safety, feasibility and potential
usefulness of hemodynamic support with Impella 2.5 in high-risk PCI."
"As high-risk PCI increasingly becomes the alternative for patients
turned down for surgery, the Europella registry demonstrates that
Impella 2.5 proves a safe and effective method of support for these
high-risk procedures," said Jose PS Henriques, M.D., Ph.D., Academic
Medical Center, University of Amsterdam. "These results are very
encouraging in indicating Impella's ability to maintain hemodynamic
support by safely unloading the left ventricle and decreasing oxygen
demand in high-risk PCI patients."
The Europella registry is the largest multicenter study ever reported
for high risk PCI conducted with Impella, including 144 consecutive
high-risk PCI patients with complex or high risk coronary lesions, such
as last remaining vessel or left main lesions, from ten European
centers, and reported the following:
Patient Population
-
Patients were older, 62% older (Mean age, 71.8 years)
-
54% had an LV ejection fraction of 30% or less
-
The prevalence of comorbidities was high and the Mean European System
for Cardiac Operative Risk Evaluation score was 8.2± 3.4
-
43% of the patients were refused for CABG
-
Left main coronary artery (LMCA) PCI, last patent vessel PCI, and
complex multivessel disease (MVD) comprised 52%, 17%, and 82% of the
cases, respectively
Device Outcomes
-
Successful passage through the femoral artery and implantation of the
Impella 2.5 into the left ventricle was achieved in all 144 patients
-
The study showed a low rate of major adverse cardiac and
cerebrovascular, 0% device malfunction and low rate of complications
confirming the safety, ease of use and potential effectiveness of the
technology for high risk PCI. The primary feasibility endpoint
included successful deployment, operation and explantation of the
Impella 2.5.
"We are pleased with the positive results from the Europella registry.
These data reinforce the Impella 2.5 clinical papers that are continuing
to be released, such as USpella, which was announced at TCT 2009," said
Michael R. Minogue, Chairman, President and Chief Executive Officer of
Abiomed.
The Europella registry in JACC may be accessed online at http://content.onlinejacc.org/cgi/content/abstract/54/25/2430?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=europella&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT
ABOUT ABIOMED
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.
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
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.
Abiomed, Inc.
Aimee Maillett, 978-646-1553
Public Relations Specialist
ir@abiomed.com