Endologix Receives IDE Approval for the Ventana(TM) Fenestrated Stent Graft System
September 06 2011 - 9:00AM
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of minimally
invasive treatments for aortic disorders, announced today that it
has received Investigational Device Exemption ("IDE") conditional
approval from the United States Food and Drug Administration
("FDA") to begin U.S. clinical trials to evaluate the Ventana™
Fenestrated Stent Graft System for the endovascular repair of
juxtarenal and pararenal aortic aneurysms. Endologix expects to
begin enrolling patients at a few centers in the U.S. before the
end of this year.
The Ventana™ device is a new aortic extension designed to be
used with the AFX® Endovascular AAA System and Xpand™ renal stent
grafts. The AFX system is commercially available in the U.S. and
expected to be available in other international markets in 2012.
The Ventana™ and Xpand™ stent grafts are not approved for marketing
in the U.S. or abroad and are restricted to investigational use
only.
U.S. National Principal Investigator Daniel G. Clair, MD
(Chairman, Department of Vascular Surgery, Cleveland Clinic
Foundation, Cleveland, OH) commented, "The initial clinical
experience with Ventana outside of the U.S. has been very positive.
International results demonstrate proof of concept for this
innovative system, which is the first off-the-shelf endovascular
option for patients with juxtarenal and pararenal aortic aneurysms.
On behalf of the Ventana IDE investigators, we look forward to
initiating the clinical program in the U.S. and furthering the
research efforts on this promising technology."
John McDermott, President and Chief Executive Officer said, "We
are delighted to receive the U.S. FDA conditional IDE approval, and
are encouraged by the initial positive outcomes with Ventana in
clinical studies outside the U.S. It is estimated that 20% of
diagnosed abdominal aortic aneurysms are not treatable with
currently approved endovascular devices. Ventana potentially
provides these patients with an innovative and less-invasive
alternative to open repair. We look forward to collaborating with
the Ventana clinical investigators on the IDE trial and are hopeful
to provide a new endovascular therapy for patients with complex
aortic aneurysms in the years ahead."
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 relating to the
clinical program for the Ventana Fenestrated Stent Graft System and
Xpand renal stent grafts, 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 development and clinical testing 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.
CONTACT: Endologix, Inc.
John McDermott, CEO
(949) 595-7200
www.endologix.com
INVESTOR CONTACTS:
The Ruth Group
Nick Laudico (646) 536-7030
Zack Kubow (646) 536-7020
Endologix (NASDAQ:ELGX)
Historical Stock Chart
From May 2024 to Jun 2024
Endologix (NASDAQ:ELGX)
Historical Stock Chart
From Jun 2023 to Jun 2024