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

IRVINE, Calif., Endologix, 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.”  

Source: Endologix, Inc.