8:33AM Endologix announces presentation of data From PEVAR randomized trial; 94% procedural technical success rate; 'significantly' reduced procedure times and time to hemostasis (ELGX) 15.63 : Co announced that data from the first prospective, multicenter, randomized clinical trial of a totally percutaneous approach (PEVAR) to endovascular abdominal aortic aneurysm repair (EVAR) was recently presented at two medical meetings. 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
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