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November 16, 2016
Two-Year EVAS FORWARD Global Registry Data Presented on Endologix's Nellix EVAS System
November 17, 2016—Endologix, Inc. announced the presentation of 2-year clinical data from the company’s EVAS FORWARD Global Registry, which were presented at the 2016 VEITHsymposium being held November 15–19, 2016 in New York City. The EVAS FORWARD Global Registry is a postmarket study that prospectively enrolled patients with abdominal aortic aneurysms (AAAs) who were treated with the Nellix endovascular aneurysm sealing (EVAS) system (Endologix, Inc.). Andrew Holden, MD, Associate Professor of Radiology at Auckland City Hospital in Auckland, New Zealand, as well as one of the Principal Investigators of the study presented the results.
According to the company, the presentation included data from a total of 300 patients enrolled in Europe and New Zealand who were treated with the Nellix system and were followed out to 2 years.
The investigators found that 37% of the patients had complex anatomies and there were no secondary interventions for type II endoleaks. Furthermore, there was 97% freedom from aneurysm-related mortality, 99% freedom from cardiovascular mortality, and 98% freedom from any persistent endoleaks at latest follow-up.
Dr. Holden commented, “The 2-year results from the EVAS FORWARD Global Registry confirm the significant potential for EVAS with Nellix to treat a broad range of patients and provide excellent results, especially within the indications for use. In addition, the continued low rates of aneurysm and cardiovascular-related mortality suggest that EVAS with Nellix may provide additional benefits beyond traditional EVAR.”
In its press release, the company stated that the Nellix EVAS system was designed to seal the entire abdominal aortic aneurysm sac and to reduce all types of endoleaks and therefore improve long-term patient outcomes. Endologix also noted that Nellix is an investigational device in the United States.
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