FDA Approval of Percutaneous EVAR

Endologix announced on April 16, 2013, that it has received US Food and Drug Administration approval of its premarket approval supplement for a broadened indication for the 21-French profile and smaller endovascular aneurysm repair (EVAR) systems to include totally percutaneous EVAR (PEVAR) based upon the outcomes of the first prospective, multicenter, randomized PEVAR trial. 

The Endologix EVAR platforms approved for the percutaneous indication include the Powerlink with IntuiTrak system and the AFX EVAR system, which are commercially available endografts.  Access-site hemostasis and vessel closure are facilitated with use of the Perclose ProGlide suture-mediated closure system (Abbott Vascular).

  This represents an important development because the results of the clinical trial validated percutaneous EVAR as a safe and reasonable approach that may offer advantages over the traditional surgical cut-down access technique — most significantly, it facilitates the use of local anesthesia for most, if not all, such procedures. But it remains to be seen whether this new on-label indication will accelerate adoption of PEVAR and quicken the pace of change. I suspect it will have a positive influence in this regard, but I would not expect a transformation of sorts anytime soon — not until devices can be appropriately thought of as “percutaneous.” And for abdominal aortic aneurysm stent-grafts, this probably means a main-body delivery system featuring an outer profile smaller than 14 French.