Endologix's AFX2 Bifurcated Endograft System Approved in Australia
December 19, 2016—Endologix, Inc. announced that the Australian Therapeutic Goods Administration has approved the AFX2 bifurcated endograft system for endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAAs). The device will be available for use in Australia beginning in 2017.
According to Endologix, AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft. The new device also facilitates percutaneous EVAR by providing the low-profile contralateral access through a 7-F introducer. AFX2 incorporates the company’s ActiveSeal technology and DuraPly expanded polytetrafluoroethylene graft material.
In the company's announcement, Vikram Puttaswamy, MD, commented, “We are pleased with the approval of AFX2 in Australia and look forward to providing this new technology to our patients. AFX2 and its unique ability to preserve the aortic bifurcation represents an important addition to our endovascular AAA treatment options.” Dr. Puttaswamy is a vascular surgeon at Sydney Vascular Surgery in Sydney, Australia.
In February 2016, Endologix announced the commencement of a limited market launch in the United States for AFX2, which was followed by a wide commercial launch in the second quarter. The US Food and Drug Administration approval of the device was announced in October 2015.