Endologix Receives FDA Approval for Visiflex Delivery System
May 24 2006 - 4:00AM
Business Wire
Endologix, Inc. (Nasdaq:ELGX) today announced receipt of U.S. Food
and Drug Administration (FDA) approval to begin marketing its
next-generation Visiflex(TM) Delivery System for use with the
Powerlink(R) System for the minimally invasive treatment of
abdominal aortic aneurysm (AAA). The Company obtained approval for
this PMA supplement in 56 days. The Company plans to introduce the
Visiflex Delivery System in the U.S. market through a controlled
launch program to further develop targeted physician feedback and
to build inventory, with full commercialization anticipated in the
fall of this year. The Visiflex Delivery System is designed to
provide improved catheter flexibility for delivery of the Powerlink
endoluminal stent graft (ELG) device. An integrated radiopaque band
marker on the outer sheath and molded component parts are expected
to enhance catheter visibility and facilitate smoother withdrawal
in difficult anatomies. The Visiflex Delivery System has been CE
Marked and used in Europe in Powerlink procedures, with very
positive physician feedback to date. "The new Visiflex Delivery
System represents one of the measures we are taking to keep on the
cutting edge of technology as we continue to expand commercial
adoption of the Powerlink System," said Paul McCormick, president
and chief executive officer of Endologix. "While our delivery
catheter has been recognized as a key strength of the Powerlink
System since initial market introduction, the Visiflex Delivery
System offers the potential to substantially heighten this
awareness among physicians with even greater ease of use." About
Endologix Endologix, Inc. develops and manufactures minimally
invasive treatments for vascular diseases. Endologix's Powerlink
System is an endoluminal stent graft (ELG) 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 the thirteenth 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, ,
the accuracy of which are necessarily subject to risks and
uncertainties, including risks related to changes in market
acceptance of the Visiflex Delivery System, all of which are
difficult or impossible to predict accurately and many of which are
beyond the control of Endologix, all as more fully described in the
risk factors and other matters set forth in Endologix's Annual
Report on Form 10-K for the year ended December 31, 2005, and
Endologix's other filings with the Securities and Exchange
Commission.
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