FDA Clears New Endologix Low-Profile Stent Graft


June 17, 2011

June 17, 2011 — Endologix Inc. received U.S. Food and Drug Administration (FDA) approval for AFX Endovascular AAA System for the treatment of abdominal aortic aneurysms (AAA). The company is introducing AFX at the annual meeting of the Society for Vascular Surgery (SVS),  June 16-18, 2011 in Chicago.

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.

In addition to AFX, the company's complete product portfolio will be highlighted at the SVS annual meeting. This includes the investigational Nellix Endovascular System and the Ventana Fenestrated Stent Graft System, both of which will be featured in symposia at SVS.

For more information: www.endologix.com