Endologix Announces First Patient Treated in Ventana(TM) U.S. Clinical Trial
January 31 2012 - 12:30PM
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative
treatments for aortic disorders, announced today that the first
patient has been enrolled in the Company's U.S. clinical trial to
evaluate the Ventana™ Fenestrated Stent Graft System for the
endovascular repair of juxtarenal and pararenal abdominal aortic
aneurysms (AAAs). The procedure was performed by Matthew Eagleton,
MD (Cleveland Clinic Foundation, Department of Vascular Surgery).
National Principal Investigator Daniel G. Clair, MD (Chairman,
Department of Vascular Surgery, Cleveland Clinic Foundation)
proctored the procedure.
Dr. Eagleton said, "We are excited to be the first
investigational site to enroll a patient in the Ventana trial using
this innovative new stent graft technology. This trial will offer
participation to patients with abdominal aortic aneurysms that
extend near or involve the renal arteries – patients who are not
treatable with any of the approved endovascular aneurysm repair
devices. The Ventana stent graft is designed with movable
fenestrations for in vivo adjustment to match the specific location
of a patient's renal arteries along the aorta, which is essential
to addressing the anatomical challenges of these aneurysms. The
Ventana system performed well and post-procedure imaging showed
that the stent graft completely sealed the aneurysm and maintained
blood flow to the kidneys."
Dr. Clair added, "The Ventana system is the first integrated,
off-the-shelf endovascular stent graft device system in a
multicenter, prospective clinical trial for patients with
juxtarenal and pararenal AAAs. The experience with our first
Ventana patient in the U.S. highlighted the fenestration movement,
ease of use, and aneurysm sealing attributes of the device and,
more importantly, provided a minimally invasive treatment option
for a patient that previously could not be offered an approved
endovascular option. We look forward to begin treating patients at
other clinical trial sites in the near future."
The multicenter, prospective, single arm Ventana clinical trial
was approved by the U.S. Food and Drug Administration under an
Investigational Device Exemption (IDE) for conduct at up to 25 U.S.
clinical sites and involving 122 patients. The trial is intended to
support a future premarket approval (PMA) application to the FDA to
provide reasonable assurances of safety and effectiveness for the
Ventana System for the endovascular repair of juxtarenal and
pararenal aneurysms in selected patients. The trial primary
endpoints will evaluate safety (major adverse events) at 30 days
and effectiveness (treatment success) at one year, with continuing
follow-up to five years.
John McDermott, President and Chief Executive Officer, said,
"Enrolling the first patient in our Ventana U.S. clinical trial is
another key milestone in the path towards bringing this important
technology to patients in the U.S. The international clinical
experience with Ventana demonstrates that it has the potential to
be the only off-the-shelf EVAR system to address approximately 20%
of AAA patients who have juxtarenal or pararenal aneurysms."
About Endologix, Inc.
Endologix, Inc. (the "Company") 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. The Ventana™
Fenestrated Stent Graft System is an investigational device.
Forward-Looking Statements
Except for historical information contained herein, this press
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: COMPANY 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
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