Endologix Announces First Patient Treated in Powerlink Trial for Large Diameter Aneurysm Necks
September 28 2005 - 4:00AM
Business Wire
Endologix, Inc. (Nasdaq:ELGX) today announced that the first
patient has been treated in Endologix ongoing suprarenal clinical
trial with the Powerlink 34 mm System, a modification of Endologix
U.S. Food and Drug Administration (FDA)-approved Powerlink(R)
System. The Powerlink 34 mm System is designed to treat abdominal
aortic aneurysm (AAA) patients with large diameter aortic necks
and, if approved, would be the only endoluminal stent graft (ELG)
for use in aneurysms with neck diameters up to 32 millimeters (mm).
The procedure was performed at Newark, Del.-based Christiana
Hospital by Drs. Mark Garcia and Sonya Tuerff. "With the Powerlink
34 mm System, we were able to treat this patient who otherwise had
limited treatment alternatives," said Dr. Garcia. "Due to the size
of his proximal aorta, this patient was not a suitable candidate
for effective treatment with any of the commercially available
ELGs, and based on his condition and age, highly invasive
conventional surgery would not have been a good option," added Dr.
Tuerff. "I was delighted by the ease of use of the Powerlink 34 mm
System. The patient recovered rapidly from this surgery and was
discharged home two days following the procedure." Paul McCormick,
Endologix president and chief executive officer, said, "The
Powerlink 34 mm System has the ability to expand the universe of
AAA patients suitable for minimally invasive ELGs as approximately
5-10% of those evaluated are excluded due to a large aortic neck
diameter." Endologix has also received FDA approval to initiate a
seven center, 60-patient protocol utilizing a large diameter
infrarenal cuff with its approved Powerlink bifurcated device. This
study, along with the ongoing suprarenal clinical trial, allows
Endologix to study alternative implant strategies to treat AAA in
those patients eligible for minimally invasive procedure. 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. In
October 2004, Endologix received approval to market the Powerlink
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 the clinical trials
and regulatory approvals, and payor acceptance of new medical
device products, 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 the Company's Annual Report on Form 10-K
for the year ended December 31, 2004, and the Company's other
filings with the Securities and Exchange Commission.
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