endovascular.es

Título: Endologix Announces Reinstatement of CE Mark for AFX® and AFX ® 2 Endovascular AAA System
Fecha: 25-01-2017
John McDermott, Chief Executive Officer of Endologix, said, "We are pleased that AFX and AFX2 are once again
available to physicians and patients in Europe. The quick reinstatement of the CE Mark is a testament to the
strong commercial clinical results achieved with the current generations of the device. Additionally, during this
process we received numerous letters and endorsements from physicians worldwide and we'd like to thank them
for their support."
The CE Mark was temporarily suspended due to reports of Type III endoleaks with a prior generation of the AFX
system. The CE Mark was reinstated based upon low rates of reported Type III endoleaks with the current
generation of AFX products, which was also outlined in a recent
letter to physicians
provided by Endologix.
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 80%, making it a leading cause of death in the United States.
Addi
tional information can be found on Endologix's website at
www.endologix.com
.
Forward Looking
Statements
This communication includes statements that may be "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, including with respect to availability for sale of AFX devices in the
EU, 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, unexpected delays in process and testing improvements and
additional regulatory requirements. Undue reliance should not be placed on forward-looking statements, which
speak only as of the date they are made. Endologix undertakes no obligation to update any forward-looking
statements to reflect new information, events or circumstances after the date they are made, or to reflect the
occurrence of unanticipated events. Please refer to Endologix's Annual Report on Form 10-K for the year ended
December 31, 2015, and Endologix's subsequent 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.
Fuente: endovascular.es

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