Endologix (NSDQ:ELGX) today announced the presentation of 2-year data from the EVAS Forward IDE trial of its Nellix stent graft for repairing abdominal aortic aneurysms, touting a high rate of freedom from endoleaks, ruptures and mortalities.
Results from the trial were presented by study principal investigator Dr. Jeffrey Carpenter of New Jersey’s Cooper Medical Schoo and Cooper Health System at the Society of Vascular Surgery’s 2017 Vascular annual meeting this week.
“The overall 2-year results for EVAS with Nellix are very encouraging. In particular, the refined IFU appears to offer excellent patient outcomes, and we look forward to validating these results in the upcoming prospective confirmatory study,” Dr. Carpenter said in a prepared statement.
Data from the trial exploring the safety and efficacy of the stent graft indicated a 94% freedom from all endoleaks, with a 97% freedom from rupture, 97% freedom from all-cause mortality and 99% freedom from cardiovascular mortality amongst all the patients. Results also indicated a 97% freedom from type II endoleaks, which the company said was the highest ever reported at 2 years.
At the 2-year follow up, patients treated with Nellix demonstrated a 96% freedom from Type Ia endoleak, migration and sac growth, Irvine, Calif.-based Endologix said.
“We would like to thank Dr. Carpenter and all the investigators for their participation in the IDE study, as well as their important contributions to the learning and evolution of EVAS. We have identified an AAA patient population that will significantly benefit from the Nellix device, and we look forward to expanding applicability with ChEVAS, and our next generation EVAS platform, in the future,” CEO John McDermott said in a press release.
In May, Endologix saw shares drop more than 30% after it revealed a 2-year setback for its Nellix stent graft for repairing abdominal aortic aneurysms.
Endologix said meetings with the FDA and “further internal analysis” led it to decide to launch a “confirmatory” trial for Nellix, which was initially delayed last November when the federal safety watchdog asked for 2-year follow-up data from the EVAS-Forward investigational device exemption study.