Endologix announces FDA approval of AFX2 Bifurcated Endograft System


Endologix announced on 13 October 2015 that it has received FDA approval for the AFX2 Bifurcated Endograft System for the treatment of abdominal aortic aneurysms. This new device is the latest innovation in the AFX Endovascular AAA family of products. Endologix plans to highlight AFX2 at the 2015 VEITHsymposium taking place 17–21 November in New York, with a commercial launch in the USA expected to begin in the first quarter of 2016.

According to Endologix, AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft. The new device also facilitates percutaneous endovascular aneurysm repair (EVAR) by providing the industry’s lowest profile contralateral access through a 7F introducer. These improvements bring together Endologix’s ActiveSeal technology, DuraPly ePTFE graft material and Vela Proximal Endograft, into an integrated new EVAR system.

John McDermott, chief executive officer of Endologix, said, “The AFX system is already uniquely positioned as the only anatomical fixation EVAR device on the market. With the approval of AFX2, we have taken a versatile platform and combined it with an easy to use, low profile delivery system. We believe this will enable more physicians to utilise AFX2 and offer its unique clinical benefits to patients. We would like to thank all the physicians who provided input into the new design and look forward to introducing AFX2 early in 2016.”