IRVINE, Calif., Feb. 15, 2011 /PRNewswire/ -- Endologix, Inc.
(Nasdaq: ELGX), developer of minimally invasive treatments for
aortic disorders, announced today the presentation of the initial
clinical results from the PEVAR Trial at the 2011 iCON
(International Congress of Endovascular Specialists) annual meeting
in Scottsdale, Arizona. Among 33
patients enrolled in the Roll-In phase of the trial, technical
success rates of 97% (access) and 100% (endovascular repair) have
been achieved, with no major adverse events observed. Patients were
discharged from the hospital at an average of 1.4 days following
the procedure.
Participating investigator and presenter Zvonimir Krajcer, MD (Director, Peripheral
Vascular Disease Service, St. Luke's Episcopal Hospital at the
Texas Heart Institute, Houston,
TX) commented, "In our multidisciplinary practice, a totally
percutaneous approach to endovascular repair with the IntuiTrak
System and Abbott's Prostar XL
closure device has demonstrated substantial patient benefits as we
recently reported in the Journal of Cardiovascular Surgery.
These initial outcomes in the PEVAR Trial roll-in phase are
consistent with the published single center data, and have served
to support initiation of the randomized phase of the trial. We are
very pleased with the initial results, and look forward to
completion of the randomized trial very soon."
The PEVAR Trial is the first multicenter, prospective,
randomized trial of totally percutaneous endovascular repair of
abdominal aortic aneurysm and is being conducted at 20 centers in
the United States under an
Investigational Device Exemption approved by the U.S. Food and Drug
Administration.
John McDermott, President and
Chief Executive Officer said, "We applaud the PEVAR Trial
investigators for their diligence and dedication to the trial, and
commitment to improving patient outcomes. We are encouraged by the
initial trial results, and look forward to completion of this trial
in the near future."
About iCON
The International Congress for Endovascular Specialists annual
meeting is presented by the Arizona Heart Foundation and the
International Society of Endovascular Specialists. The
meeting provides a multidisciplinary forum for the discussion of a
wide range of endovascular topics including acute stroke, carotid
artery disease, structural heart disease, heart failure therapies,
thoracic and abdominal aortic pathologies, and peripheral vascular
disorders. There are also concurrent cardiac sessions addressing
chronic heart failure, arrhythmias, and percutaneous valve
replacement. The meeting is being held from February 13-17, 2011 in Scottsdale, Arizona. More information is
available at www.iconmeeting.org.
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive
treatments for aortic disorders. The Company's flagship product is
the Powerlink® System, which is an endovascular stent graft for the
treatment of abdominal aortic aneurysms (AAA). AAA is a
weakening of the wall of the aorta, the largest artery in the body,
resulting in a balloon-like enlargement. Once AAA develops, it
continues to enlarge and, if left untreated, becomes increasingly
susceptible to rupture. The overall patient mortality rate for
ruptured AAA is approximately 75%, making it a leading cause of
death in the U.S. Additional information can be found on
Endologix's Web site at www.endologix.com.
Forward-Looking Statements
Except for historical information contained herein, this news
release contains forward-looking statements, the accuracy of which
are necessarily subject to risks and uncertainties, all of which
are difficult or impossible to predict accurately and many of which
are beyond the control of Endologix. Many factors may cause actual
results to differ materially from anticipated results, including
the success of sales efforts for the Powerlink System and related
new products, product research and development efforts, and other
economic, business, competitive and regulatory factors. The Company
undertakes no obligation to update its forward looking statements.
Please refer to the Company's Annual Report on Form 10-K for the
year ended December 31, 2009, and the
Company's other filings with the Securities and Exchange
Commission, for more detailed information regarding these risks and
other factors that may cause actual results to differ materially
from those expressed or implied.
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COMPANY
CONTACT:
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INVESTOR
CONTACTS:
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Endologix, Inc.
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The Ruth Group
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John McDermott, CEO
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Nick Laudico (646)
536-7030
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(949) 595-7200
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Zack Kubow (646)
536-7020
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www.endologix.com
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SOURCE Endologix, Inc.