Endologix Announces FDA Approval of IntuiTrak, an Innovative New Delivery System for the Powerlink AAA Device
October 22 2008 - 4:00AM
Business Wire
Endologix, Inc. (NASDAQ:ELGX) today announced U.S. Food and Drug
Administration (FDA) approval of the IntuiTrak� Delivery System.
This innovative new system will be used for the minimally invasive
delivery and deployment of the Powerlink stent graft, which is
indicated for the endovascular repair of abdominal aortic aneurysms
(AAA). The company plans to conduct a limited market release over
the next several months and expects a full commercial launch in the
U.S. in the second quarter 2009. IntuiTrak has a novel design and
deployment mechanism that simplifies delivery of the unibody
bifurcated Powerlink device. The low-profile delivery system
features enhanced flexibility, advanced hemostasis control and a
hydrophilic coating to facilitate smooth delivery, particularly in
patients with limited or difficult vascular access. Additionally,
the delivery catheter has an integrated sheath to facilitate the
introduction of ancillary devices during the endovascular AAA
procedure. This feature avoids the need for exchanges, thereby
having the potential to reduce procedure time, blood loss and
minimize vessel trauma. �The procedural advantages of the IntuiTrak
Delivery System, combined with the exceptional long-term clinical
results of the Powerlink device, provide physicians with a
compelling technology to treat their AAA patients,� said John
McDermott, Endologix President and CEO. �We are excited to begin
working with physicians on the training and roll-out of IntuiTrak
and expect a full market release in the second quarter of 2009.�
About Endologix Endologix, Inc. develops and manufactures minimally
invasive treatments for vascular diseases. Endologix's Powerlink
System is an endoluminal 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 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, 2007, 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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