Endologix
Feb 29, 2016

Endologix Announces First U.S. Commercial Implant of AFX®2 Bifurcated Endograft System

IRVINE, Calif., Feb. 29, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that the first U.S. commercial implant of the Company's AFX®2 Bifurcated Endograft System was performed at Maine Medical Center (MMC), in Portland, ME. The procedure was performed by Paul Bloch, M.D., Associate Professor at Tufts University School of Medicine and vascular surgeon at MMC.

Dr. Bloch commented, "We are excited to be the first hospital to offer the unique benefits of the AFX2 system to patients in the U.S. The enhanced delivery system provides improved visibility during device deployment and facilitates an overall faster and easier procedure. The procedure was a success and post-procedure imaging confirmed that we achieved accurate placement and seal of the aneurysm."

Dr. Sean Lyden, Chairman of Vascular Surgery, Cleveland Clinic and Dr. Dan Clair, Chairman Emeritus, Cleveland Clinic performed their first procedure with AFX2 and commented, "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."

AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft.  The new device also facilitates percutaneous endovascular aneurysm repair, or PEVAR, by providing the 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, "We are very pleased with the first AFX2 procedures in the U.S. and gratified that the patients' aneurysms have been successfully treated. We would like to thank Drs. Bloch, Lyden and Clair for leading the successful procedures and to all the physicians who provided input into the development of AFX2. We expect to continue with a limited market introduction of AFX2 and make the device more widely available in the U.S. in the second quarter. We believe that the combination of AFX2, together with the recently introduced Ovation iX AAA system, enables physicians in the U.S. to choose the best device for each individual patient."  

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.

Forward-Looking Statements
This communication includes statements that may be "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the benefits of the AFX2 system and the anticipated market release and commercial launch of the AFX2 system, 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 the market release and commercial launch of the AFX2 system, unanticipated clinical results for the AFX2 system and clinician acceptance of the AFX2 system.  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.

 

ENDOLOGIX CONTACT:

Endologix, Inc.

John McDermott, CEO

Vaseem Mahboob, CFO

(949) 595-7200

www.endologix.com



INVESTOR CONTACTS:

The Ruth Group

Nick Laudico (646) 536-7030

Zack Kubow (646) 536-7020

Source: Endologix

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