FDA Classifies Previous Endologix AFX Safety Notice as Class I Recall

IRVINE, Calif.–(BUSINESS WIRE)–Endologix® Inc. (Nasdaq: ELGX), a developer and marketer of innovative
treatments for aortic disorders, announced today that it has received
notice that the U.S. Food and Drug Administration (FDA) has classified a
voluntary recall action that Endologix took in July of this year as a
Class I recall. The July recall involved Endologix’s issuance of a
Safety Notice to healthcare professionals (HCPs) using the AFX®
Endovascular AAA System.

The Safety Notice, dated 20 July 2018, provided updated information on
comparative AFX Type III endoleak rates, patient-tailored surveillance
recommendations, and recommendations for intervening through an AFX
device or re-intervening on an AFX device. No product was removed from
the field as part of this recall.

The July 2018 Safety Notice followed several earlier communications.
Safety Notices from Endologix issued in late 2016 and early 2017
requested that all remaining AFX Strata devices be returned from the
field and emphasized that Endologix had not manufactured AFX Strata
grafts since 2014. On September 28, 2017, the FDA issued a letter to
HCPs to raise awareness of an increased occurrence of Type III endoleaks
after endovascular aneurysm repair (EVAR). On June 19, 2018, the FDA
issued an updated letter to HCPs indicating the increased risk for Type
III endoleak appears to be specific to one device at this time, the AFX
with Strata device. (https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm611039.htm)

“As outlined at our Investor Day on October 2, 2018, the AFX Strata
product was removed from global inventory in the first half of 2017. Our
current commercially available versions of the AFX system, the AFX
DuraplyTM and AFX2TM products, are manufactured using a different ePTFE
processing methodology and include additional product improvements,”
noted John Onopchenko, Chief Executive Officer of Endologix. “These AFX
Duraply and AFX2 products, while part of the July 2018 Safety Notice
providing updated recommendations to HCPs on how to re-intervene on or
through these products, were not the subject of the voluntary product
removal actions in December 2016/January 2017. Furthermore, AFX Duraply
and AFX2 products were not the subject of the June 19, 2018 FDA letter
to HCPs. Through our comprehensive system of post-market surveillance,
anonymized registry data, and the only randomized trial to compare EVAR
systems (the LEOPARD trial), we have a strong and growing evidence base
that supports the use of the AFX Duraply and AFX2 systems for patients
with AAA. We are proud of, and committed to, advancing our collaborative
work with the FDA on behalf of our patients, customers, and the broader
clinical community.”

About Endologix

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. For more information, visit www.endologix.com.


Endologix, Inc.
Vaseem Mahboob, CFO, (949) 595-7200


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