IRVINE, Calif., June 15, 2011 /PRNewswire/ -- Endologix, Inc.
(Nasdaq: ELGX), developer and marketer of minimally invasive
treatments for aortic disorders, announced today that it has
received U.S. Food and Drug Administration (FDA) approval for its
next generation product, the AFX™ Endovascular AAA System, for the
treatment of abdominal aortic aneurysms (AAA). Endologix is
introducing AFX at the Annual Meeting of the Society for Vascular
Surgery (SVS), which is taking place June
16-18, 2011 in Chicago, IL.
AFX builds upon Endologix's clinically proven anatomical
fixation technology with a new low profile, highly precise
delivery system and a state of the art, proprietary stent graft
material (STRATA™). The key features of the AFX System
include:
- Low profile 17Fr introducer sheath – The entire family
of AFX stent grafts, which range in diameter from 13 to 34
millimeters, are delivered through a low profile,
hydrophilically-coated 17Fr introducer sheath – obviating the
need for exchanges. Notably, this sheath technology, combined with
the System's percutaneous (9Fr) contralateral access, makes AFX the
lowest profile device approved in the U.S. for the treatment of the
most common AAAs – those with aortic neck diameters of 22
millimeters or larger.
- Precise delivery and deployment – The AFX delivery
system features an ergonomic dial mechanism that provides
physicians with precise, controlled stent graft positioning and
deployment. These features were designed with significant
input from endovascular specialists globally.
- STRATA expanded polytetrafluoroethylene (ePTFE) graft –
AFX stent grafts are constructed using Endologix's proprietary new
STRATA graft material. STRATA is a durable, highly conformable
material featuring enhanced stent graft sealing technology.
John McDermott, President and
Chief Executive Officer of Endologix, commented, "Achieving FDA
approval for the AFX System is an important milestone for Endologix
and for the physicians and patients we serve. The advances
incorporated into the AFX System will give physicians even more
confidence and precision in treating a wide range of AAA anatomies.
The SVS annual meeting provides an ideal venue to begin educating
physicians on the new system, which we expect to be commercially
available within a couple of months following the necessary sales
force training and inventory build."
In addition to AFX, the Company's complete product portfolio
will be highlighted at the SVS Annual Meeting. This includes
the investigational Nellix® Endovascular System and the Ventana™
Fenestrated Stent Graft System, both of which will be featured in
symposia at SVS.
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive
treatments for aortic disorders. The Company's focus is
endovascular stent grafts 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 uncertainties related to the introduction and clinical
acceptance of new products,. 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, 2010, 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.
COMPANY
CONTACT:
|
INVESTOR
CONTACTS:
|
|
Endologix, Inc.
|
The Ruth Group
|
|
John McDermott, CEO
|
Nick Laudico (646)
536-7030
|
|
(949) 595-7200
|
Zack Kubow (646)
536-7020
|
|
www.endologix.com
|
|
|
|
|
|
|
SOURCE Endologix, Inc.