Endologix Announces FDA Approval of Powerlink XL System for the Treatment of Abdominal Aortic Aneurysms in Patients with Larg...
October 17 2008 - 12:02PM
Business Wire
Endologix, Inc. (Nasdaq:ELGX) today announced U.S. Food and Drug
Administration (FDA) approval of the PMA supplement for its
Powerlink XL� System, which includes new suprarenal stent grafts as
well as the new Powerlink XL stent graft. This approval
substantially broadens the Company�s treatment indications for the
Powerlink System, which is used in the minimally invasive treatment
of abdominal aortic aneurysms (AAA). The Powerlink XL System was
evaluated in an IDE clinical study and approved for the treatment
of AAA patients with proximal aortic necks between 23 millimeters
and 32 millimeters. �This approval is important for patients with
AAA, because the Powerlink XL System offers the lowest profile
catheter of all commercially available devices in the U.S.
indicated for aortic necks greater than 26 millimeters,� said John
McDermott, Endologix President and CEO. The low profile Powerlink
XL System expands the market for AAA procedures by enabling
treatment in patients with limited or difficult vascular access. In
addition to its low profile, the Powerlink and Powerlink XL Systems
are the only commercially available AAA devices with proximal
extensions offered in both infrarenal and suprarenal
configurations. By providing both design options, Endologix enables
physicians to choose the most optimal device to treat a wide range
of patient anatomies. Furthermore, the Powerlink XL opens a new
market segment to Endologix, as approximately 15% of endovascular
AAA procedures are performed in patients with aortic necks greater
than 26 millimeters. �We already have a reputation for providing
minimally invasive solutions for AAA patients with complex
anatomies and this approval further strengthens our position,�
added Mr. McDermott. �We look forward to launching this innovative
technology and expanding the treatment options for AAA patients in
the U.S.� 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
relating to the continued growth of Endologix�s business and an
increasing share of the endovascular AAA market, 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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