Endologix (NSDQ:ELGX) said this week that data from a pivotal trial of its Nellix system for treating abdominal aortic aneurysms met its primary safety endpoint, reporting endoleaks in 9 patients.
Irvine, Calif.-based Endologix said the 150-patient trial showed a 100% procedural success rate with no device-related adverse events, aneurysm ruptures, conversions, limb thromboses, stent fractures or kinking after 30 days.
The rate of major adverse events was 2.7% and included 1 death due to multi-system failure and 1 patient with bowel ischemia. Nine endoleaks were reported in the trial, 8 of which were type II leaks, the company said.
Investors sent ELGX shares down 1.7% the day of the announcement to a $16.17 close, prompting an SEC filing from Endologix noting that 5 of the type II endoleaks resolved after 6 months.
Endoleaks occur when blood continues to flow into the aneurysm sac after endovascular aneurysm repair. Type I leaks occur at the attachment site of the device used to treat the aneurysm. Type II leaks, which are the most common, occur through retrograde flow of blood through branch vessels.
Endologix won CE Mark approval in the European Union in September 2012 and landed IDE approval form the FDA for the pivotal trial in January 2014.
