Healthcare Industry News: abdominal aortic aneurysm
News Release - October 12, 2015
Endologix Announces FDA Approval of AFX(R)2 Bifurcated Endograft SystemIRVINE, Calif., Oct. 12, 2015 -- (Healthcare Sales & Marketing Network) -- Endologix, Inc. (ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the AFX(R)2 Bifurcated Endograft System for the treatment of abdominal aortic aneurysms (AAA). This new device is the latest innovation in the AFX Endovascular AAA family of products. Endologix plans to highlight AFX2 at the 2015 VEITH symposium taking place November 17-21 in New York City, with a commercial launch in the U.S. expected to begin in the first quarter of 2016.
AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft. The new device also facilitates percutaneous EVAR by providing the industry's lowest profile contralateral access through a 7F introducer. These improvements bring together Endologix's ActiveSeal(TM) technology, DuraPly(TM) ePTFE graft material and VELA(TM) Proximal Endograft, into an integrated new EVAR (endovascular aneurysm repair) 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 utilize AFX2 and offer its unique clinical benefits to patients. We'd like to thank all the physicians who provided input into the new design and look forward to introducing AFX2 early in 2016."
About Endologix, Inc.
Endologix, Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it a leading cause of death in the U.S. Additional information can be found on Endologix's website at www.endologix.com.
Cautions Regarding Forward-Looking Statements
Except for historical information contained herein, this news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to anticipated launch of AFX2, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including delays in production of this new product. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Endologix undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Endologix's Annual Report on Form 10-K for the year ended December 31, 2014, and Endologix's subsequent filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.
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