Tag: AFX2

AFX2

Endologix receives US FDA approval of PMA supplement for AFX2 system

Endologix recently announced that it has received US Food and Drug Administration (FDA) approval for a premarket approval (PMA) supplement relating to the AFX2...
AFX2

Endologix receives CE mark certification under EU-MDR for AFX2 endovascular AAA...

Endologix recently announced that is has received CE mark certification under the new EU Medical Devices Regulation (EU-MDR) for its AFX2 endovascular abdominal aortic...

Disruptive technology and high-quality clinical evidence: An Endologix transformation

NOTE: This video is ONLY available to watch in selected countries and geographies  Endologix president and CEO, Matt Thompson (Irvine, USA), discusses how the...

CE mark reinstated for Endologix AFX and AFX2 systems

The CE mark for Endologix’ AFX and AFX2 endovascular abdominal aortic aneurysm systems has been reinstated, effective immediately.  The CE mark was temporarily suspended due...

Endologix resumes shipments of all sizes of AFX2 systems

Endologix has resumed shipments of all sizes of AFX2 endovascular abdominal aortic aneurysm systems. The large diameter sizes of AFX2 were placed on a temporary...

Endologix provides physicians with updated AFX information

Endologix has issued a letter to physicians with updated information about the AFX endovascular abdominal aortic aneurysm system. The voluntary letter, issued after discussions with...

Australian Therapeutic Goods Administration approves Endologix’ AFX2 bifurcated endograft system

The Australian Therapeutic Goods Administration (TGA) has approved Endologix’ AFX2 bifurcated endograft system for inclusion on the Australian Register of Therapeutic Goods. The TGA...