The multicenter, prospective, randomized PEVAR trial, which enrolled 191 (41 roll-in patients and 150 randomized patients), is designed to support the safety and effectiveness of the company’s IntuiTrak endovascular delivery system and Powerlink family of stent grafts.
The trial includes a pre-close technique, which is facilitated by Abbott’s Prostar XL Percutaneous Vascular Surgical System or Perclose ProGlide Suture-Mediated Closure System.
In the study,100 patients underwent percutaneous EVAR with closure facilitated by either the Prostar XL or Perclose ProGlide device, and 50 patients underwent standard EVAR.
Endologix president and CEO John McDermott said the results from the roll-in phase of the trial were very promising with 95% technical success and an average 1.7-day length of hospital stay.
After receiving the US Food and Drug Administration (FDA) approval of the Investigational Device Exemption (IDE), Endologix has integrated the IntuiTrak delivery system and Powerlink stent grafts into a single next-generation platform, the AFX Endovascular AAA System, which was introduced in August 2011.
Endologix said it expects to submit a supplement to its premarket approval application (PMA) with the primary endpoint results to request FDA approval for this PEVAR indication during the second quarter of 2012.
