Endologix Says Primary Trial Endpoint Met from PREVAR Randomized Trial
The presentations by Dr. Krajcer and Dr. Nelson reported the randomized trial results comparing PEVAR using the Endologix (NASDAQ: ELGX) 21Fr (OD) sheath based system delivered using a percutaneous approach (the 'pre-close' technique) using the Perclose ProGlide® Suture-Mediated Closure System^1, made by healthcare company Abbott, with surgical access EVAR. Key points from the trial include:
* The primary trial endpoint was met (P<.0036), definitively demonstrating the non-inferiority 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 non-inferiority to surgical EVAR persisted through the final 6-month follow-up
The PEVAR Trial was designed to support the safety and effectiveness of the Company's 21Fr and smaller profile EVAR platforms, including the Powerlink^® with IntuiTrak System and the AFX™ Endovascular AAA System in the percutaneous treatment of abdominal aortic aneurysm. The Company anticipates the full data from the presentation made by Dr. Nelson will be published in the Journal of Vascular Surgery during the second quarter 2013.
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