FDA Classifies Previous Endologix AFX Safety Notice as Class I Recall
October 05 2018 - 5:46PM
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.
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INVESTOR:Endologix, Inc.Vaseem Mahboob, CFO, (949) 595-7200
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