New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
January 28, 2013
09:10 EDTELGXEndologix presents data from PEVAR randomized trial
Endologix announced that data from the first prospective, multicenter, randomized clinical trial of a totally percutaneous approach, or PEVAR, to endovascular abdominal aortic aneurysm repair, or EVAR, was recently presented at two medical meetings. Key points from the trial include the primary trial endpoint was met, 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. Likewise, mean time to hemostasis was reduced following PEVAR by 13 minutes, 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, and the PEVAR non-inferiority to surgical EVAR persisted through the final 6-month follow-up.
News For ELGX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
November 21, 2014
07:16 EDTELGXEndologix trial results 'highly encouraging,' says Stifel
Subscribe for More Information
November 20, 2014
07:13 EDTELGXCanaccord to hold a forum
Subscribe for More Information
November 18, 2014
11:00 EDTELGXEndologix to host investor meeting
Subscribe for More Information
07:11 EDTELGXEndologix completes patient enrollment in Nellix EVAS FORWARD-IDE clinical trial
Endologix announced that it has completed patient enrollment in the EVAS FORWARD-IDE clinical trial, the company's U.S. pivotal clinical trial designed to evaluate the safety and effectiveness of the Nellix EndoVascular Aneurysm Sealing System for the endovascular repair of infrarenal abdominal aortic aneurysms, or AAA. Primary endpoint analysis results at one-year and beyond will be used to support the company's premarket approval, or PMA, application to the FDA for the Nellix EVAS System. The EVAS FORWARD-IDE clinical trial enrolled 179 patients at 29 centers in the U.S. and Europe. Enrollment under an extended investigation phase is anticipated to begin shortly and will continue during the pivotal trial follow-up period and PMA preparation/review process. Based on current assumptions and timelines, the company anticipates FDA approval of the Nellix System in the U.S. before the end of 2016.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use