Endologix Begins Launch of the AFX2 Bifurcated Endograft System for EVAR

February 29, 2016—Endologix, Inc. announced the commencement of a limited market launch in the United States for the company's AFX2 bifurcated endograft system for endovascular aneurysm repair (EVAR). The company expects to continue with a limited market introduction of AFX2 and make the device more widely available in the United States in the second quarter of 2016. In October 2015, Endologix announced US Food and Drug Administration approval for the AFX2 EVAR system for the treatment of abdominal aortic aneurysms.

According to the company, the AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft. It also facilitates percutaneous EVAR by providing low-profile contralateral access through a 7-F introducer. The device incorporates Endologix’s ActiveSeal technology, DuraPly expanded polytetrafluoroethylene graft material, and the Vela proximal endograft into an integrated EVAR system.

Paul Bloch, MD, performed the first commercial implant of the device at the Maine Medical Center in Portland, Maine. Dr. Bloch is an associate professor at Tufts University School of Medicine in Boston, Massachusetts.

In the company’s announcement, Dr. Bloch commented, “We are excited to be the first hospital to offer the unique benefits of the AFX2 system to patients in the United States. The enhanced delivery system provides improved visibility during device deployment and facilitates an overall faster and easier procedure. The procedure was a success and postprocedure imaging confirmed that we achieved accurate placement and seal of the aneurysm.”

At the Cleveland Clinic in Cleveland, Ohio, Sean Lyden, MD, Chairman of Vascular Surgery, and Dan Clair, MD, Chairman Emeritus, performed their first procedure with AFX2. The physicians commented in the Endologix press release, “The AFX2 system combines the unique clinical benefits of anatomical fixation with an easier-to-use, lower-profile delivery system. We are pleased to be amongst the first users of the new AFX2 system and are excited to offer this next-generation system to our patients.”