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Endologix Inc Announces FDA Approval of First Percutaneous Indication for Endovascular Abdominal Aortic Aneurysm Repair

Tuesday, 16 Apr 2013 11:30am EDT 

Endologix Inc announced that it has received U.S. Food and Drug Administration (FDA) approval of its premarket approval (PMA) supplement for a broadened indication for the Company's 21Fr profile and smaller EVAR systems to include totally percutaneous endovascular aneurysm repair (PEVAR) based upon the outcomes of the first prospective, multicenter, randomized clinical trial (The PEVAR Trial). The Endologix EVAR platforms include the Powerlink with IntuiTrak System and the AFX Endovascular AAA System, which are the first and only among commercially available endografts to achieve the totally percutaneous labeling expansion facilitated using the Perclose ProGlide Suture-Mediated Closure System made by healthcare company Abbott. The Company expects to begin training physicians in the U.S. on the PEVAR procedure in the second quarter 2013. The FDA approval provides the first clinical validation of PEVAR in a multicenter setting using the Company's fully integrated, sheath-based EVAR systems that already had the industry's only contralateral standard percutaneous (9Fr) indication. 

Company Quote

0.17 +1.19%
11 Jul 2014