Endologix receives FDA approval for the AFX Endovascular Abdominal Aortic Aneurysm System


On 17 June, Endologix announced that it has received FDA approval for its next generation product, the AFX Endovascular Abdominal Aortic Aneurysm System. Endologix introduced AFX at the Annual Meeting of the Society for Vascular Surgery (SVS), which took place in Chicago, USA.

AFX builds upon Endologix’s clinically proven anatomical fixation technology with a new low profile, highly precise delivery system and a state of the art, proprietary stent graft material (Strata). The key features of the AFX system include:

  • Low profile 17F introducer sheath – The entire family of AFX stent grafts, which range in diameter from 13 to 34 millimeters, are delivered through a low profile, hydrophilically-coated 17F introducer sheath obviating the need for exchanges. Notably, this sheath technology, combined with the system’s percutaneous (9F) contralateral access, makes AFX the lowest profile device approved in the US for the treatment of the most common abdominal aortic aneurysm those with aortic neck diameters of 22 millimeters or larger.
  • Precise delivery and deployment – The AFX delivery system features an ergonomic dial mechanism that provides physicians with precise, controlled stent graft positioning and deployment. These features were designed with significant input from endovascular specialists globally.
  • Strata – Expanded polytetrafluoroethylene (ePTFE) graft AFX stent grafts are constructed using Endologix’s proprietary new Strata graft material. Strata is a durable, highly conformable material featuring enhanced stent graft sealing technology.

John McDermott, president and chief executive officer of Endologix, commented, “Achieving FDA approval for the AFX system is an important milestone for Endologix and for the physicians and patients we serve. The advances incorporated into the AFX system will give physicians even more confidence and precision in treating a wide range of abdominal aortic aneurysm anatomies. The SVS annual meeting provides an ideal venue to begin educating physicians on the new system, which we expect to be commercially available within a couple of months following the necessary sales force training and inventory build.”