Endologix Announces FDA Approval of the IntuiTrak Express Delivery System
March 10 2009 - 4:00AM
Business Wire
Endologix, Inc. (NASDAQ: ELGX) today announced U.S. Food and
Drug Administration (FDA) approval of the IntuiTrak� Express
Delivery System for the Powerlink XL� stent graft. The IntuiTrak
Express incorporates novel design, delivery and deployment features
and enables delivery of the Powerlink XL stent graft through the
IntuiTrak 19Fr introducer sheath during the endovascular repair of
abdominal aortic aneurysms (AAA) in patients with aortic necks up
to 32mm in diameter.
Approval of the IntuiTrak Express provides additional treatment
options to physician users and includes a 21Fr IntuiTrak
stand-alone delivery system for the Powerlink XL stent grafts that
incorporates its own integrated, hydrophilically coated introducer
sheath with advanced hemostasis control.
The family of IntuiTrak Delivery Systems, first approved for
U.S. commercialization in October 2008, represents an array of
low-profile delivery systems with enhanced flexibility, advanced
hemostasis control and hydrophilic coating to facilitate smooth
delivery, particularly in patients with limited or difficult
vascular access. The integrated introducer sheath eliminates the
need for sheath exchanges in introducing ancillary devices during
the endovascular AAA procedure, thereby offering the potential to
reduce procedure time and blood loss, and minimize vessel
trauma.
�The IntuiTrak Express delivers our large diameter 34-millimeter
proximal extensions through a 19Fr Introducer Sheath, making it the
lowest profile U.S.-approved AAA device for the repair of large
neck AAA. We believe this unique combination of a low-profile
delivery system and the exceptional clinical results demonstrated
in the Powerlink XL clinical trial offers a clear competitive
advantage,� said John McDermott, Endologix President and CEO. �We
plan to conduct a limited market release with the IntuiTrak Express
over the next several months and expect a full commercial launch in
the U.S. in the third quarter of 2009. This is our fourth FDA
approval in the past six months, which positions Endologix for
continued growth in 2009 and the years ahead.�
About Endologix
Endologix, Inc. develops and manufactures innovative therapies
for aortic disorders. The company�s IntuiTrak System is an
endovascular stent graft for treating 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.
Except for historical information contained herein, this news
release contains forward-looking statements specifically including
the expected market launch and physician acceptance of the
Endologix IntuiTrak Express Delivery System, 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. 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, 2008, 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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