Four-Year Patient Follow-up Data Support Durability of Endologix's Powerlink System
November 21 2005 - 4:00AM
Business Wire
Endologix, Inc. (Nasdaq:ELGX) today announced that four-year
patient follow-up data from the Company's Powerlink(R) System
pivotal clinical trial support the durability of the Powerlink as
an endoluminal stent graft (ELG) for the treatment of abdominal
aortic aneurysms (AAA). Rodney A. White, M.D., Professor of Surgery
at UCLA School of Medicine and Chief of Vascular Surgery at
Harbor-UCLA Medical Center, presented the data at the VEITH
symposium(TM) in New York on Saturday, November 19. Dr. White's
presentation, "Factors Contributing to True and Apparent Graft
Migration After EVAR with the Powerlink Endograft: The Importance
of AAA Sac Remodeling," included data from the 192 test patients
treated with the minimally invasive Powerlink System in the pivotal
trial with a mean follow-up time of 30.20 months and a maximum
follow-up time of 48.62 months. Of the 192 test patients, Dr. White
reported that only 24 to date have required secondary procedures.
The majority of these patients were treated for Type II endoleak,
indicating that the need for secondary procedure was not device
specific. Additionally, Dr. White announced highlights from 53
patients followed for 48 months that included: -- 97.9% were free
from AAA mortality -- There were no reported graft material
failures -- There were no reported stent fractures -- Aneurysm
remodeling continues, as noted by a continued reduction in both
aortic sac diameter and volume "We were exceptionally pleased with
the positive four-year data presented at the VEITH symposium, which
is an important conference in reaching thought leaders in the
endovascular community," said Endologix President and CEO Paul
McCormick. "We believe this data that provides evidence of our
device's durability over time will further support
commercialization of the Powerlink System." 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.
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