FDA Approval of Percutaneous Endovascular Aneurysm Repair

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

Data from the PEVAR Trial was presented at the 37th Annual Meeting of the Southern Association for Vascular Surgery (SAVS) and the 25th Annual International Symposium on Endovascular Therapy (ISET) in January. Key data points were as follows:

  • The primary trial endpoint was met (P<.0036), definitively demonstrating the noninferiority of PEVAR using the ProGlide closure device to surgical EVAR.
  • A 94% procedural technical success rate was achieved in a multicenter setting.
  • Mean procedure time was reduced in PEVAR patients by 34 minutes (P=.006). Likewise, mean time to hemostasis was reduced following PEVAR by 13 minutes (P=.002).
  • PEVAR patients required significantly fewer concomitant procedures.
  • Favorable trending of PEVAR in several clinical utility outcomes including reduced anesthesia time, reduced blood loss and need for transfusion, shorter hospital length of stay, and less analgesics prescribed for groin pain.
  • The PEVAR noninferiority to surgical EVAR persisted through the final 6-month follow-up.

Dr. Criado discussed this expanded indication for PEVAR in Vascular Disease Management’s June 2013 editorial.

“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,” writes Dr. Criado. “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.”

See related articles on percutaneous EVAR in VDM.


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