FDA Clears Endologix Low-Profile Stent Graft

The Endologix AFX Endovascular AAA System is for the treatment of abdominal aortic aneurysms (AAA). AFX builds upon previous 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 17 French 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 17 French introducer sheath – eliminating the need for exchanges. This sheath technology, combined with the system's percutaneous (9 French) contralateral access, makes AFX the lowest-profile device approved in the U.S. for the treatment of the most common AAAs – 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.

STRATA expanded polytetrafluoroethylene (ePTFE) graft – AFX stent grafts are constructed using the new STRATA graft material. STRATA is a durable, highly conformable material featuring enhanced stent graft sealing technology.

The device was released ion June 2011.

For more information: www.endologix.com