News | Endovascular Aortic Repair | October 08, 2018

FDA Classifies Previous Endologix AFX Safety Notice as Class I Recall

Safety notice was related to increased occurrence of Type III endoleaks after endovascular aneurysm repair (EVAR)

FDA Classifies Previous Endologix AFX Safety Notice as Class I Recall

October 8, 2018 — Endologix Inc. 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 July 20, 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 Sept. 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. 

“As outlined at our Investor Day on Oct. 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 Duraply and AFX2 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.”

For more information: www.endologix.com


Related Content

News | Endovascular Aortic Repair

June 19, 2024 — Stereotaxis, a pioneer and global leader in surgical robotics for minimally invasive endovascular ...

Home June 19, 2024
Home
News | Endovascular Aortic Repair

October 30, 2023 — -egnite, Inc., a leading cardiovascular digital health company, announced today that novel research ...

Home October 30, 2023
Home
News | Endovascular Aortic Repair

December 5, 2022 — Imagen Technologies, Inc. announced the U.S. Food and Drug Administration's 510(k) clearance of the ...

Home December 05, 2022
Home
News | Endovascular Aortic Repair

October 26, 2022 — Thousands of people have new hope for treatment of thoracic aortic arch disease and University ...

Home October 26, 2022
Home
News | Endovascular Aortic Repair

March 22, 2022 – A retrospective evaluation of 600 fenestrated-branched endovascular aortic repairs for the treatment of ...

Home March 22, 2022
Home
News | Endovascular Aortic Repair

February 18, 2022 – Front Line Medical Technologies, Inc. today announced the expanded availability and distribution of ...

Home February 18, 2022
Home
News | Endovascular Aortic Repair

May 12, 2021 — Preliminary results of a clinical trial, presented today at the AATS 101st Annual Meeting, showed that a ...

Home May 12, 2021
Home
News | Endovascular Aortic Repair

February 23, 2021 — Medtronic has voluntarily issued a global recall of unused Medtronic Valiant Navion thoracic stent ...

Home February 23, 2021
Home
News | Endovascular Aortic Repair

January 31, 2020 – The Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) released new reporting ...

Home January 31, 2020
Home
News | Endovascular Aortic Repair

January 29, 2020 – The presence of a blood clot on the wall of the aorta in people with abdominal aortic aneurysms (AAA) ...

Home January 29, 2020
Home
Subscribe Now