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The presentations by Dr. Krajcer and Dr. Nelson reported the randomized trial
results comparing PEVAR using the Endologix
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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