Endologix has announced the presentation of updated clinical data from the company’s EVAS FORWARD Global Registry, a post-market study that prospectively enrolled patients with abdominal aortic aneurysms who were treated with the Nellix endovascular aneurysm sealing system.
Andrew Holden, associate professor of Radiology at Auckland City Hospital, Auckland, New Zealand, and one of the principal investigators of the EVAS FORWARD Global Registry, presented the results at the 2015 VEITH symposium (17–21 November, New York, USA). The Nellix system is approved for investigational use only in the USA.
Global Registry data includes a total of 300 patients with a mean follow-up of 14 months. Key highlights from the data included:
- 33% of patients treated had complex abdominal aortic aneurysm anatomies
- Low aneurysm-related mortality (0.4%) and overall major adverse events (5.9%)
- The number of patients with an endoleak at one-year follow-up was 0.7%
- Low re-intervention rate for limb occlusion of 1%
- 95% overall survival through year one.
These data continue to support positive outcomes in a patient population that had no screening or anatomical restrictions at enrolment, and constitute the broadest range of aortic anatomies for any abdominal aortic aneurysm study, says Endologix.
Holden commented, “The data from the Nellix EVAS FORWARD Global Registry continue to show promise for endovascular aneurysm sealing to become a leading therapy in the treatment of abdominal aortic aneurysm patients. The results show low rates of endoleaks, reinterventions and mortality in a patient population that includes a broad range of abdominal aortic aneurysm anatomies, including many complex cases. In particular, the 0.7% endoleak incidence at one-year represents the lowest overall rate ever reported for any commercially available endovascular device treating aneurysms. In addition, the low aneurysm-related mortality and major adverse events rates provide an encouraging look at Nellix’s positive impact on overall patient health.”
The Nellix system is designed to seal the entire aneurysm sac. Endologix says that it is the first and only endovascular aneurysm sealing product and was developed to reduce all types of endoleaks, improve stability and long-term patient outcomes. From October 2013 to September 2014, clinical investigators enrolled 300 patients treated with the Nellix system at centres in Europe and New Zealand. The study includes core lab assessment of computed tomography scans and independent physician adjudication of outcomes.
John McDermott, chairman and chief executive officer of Endologix, said, “The presentation of positive one-year follow-up data from the Nellix EVAS FORWARD Global Registry confirms the positive results from earlier data presentations and adds to our confidence in the long-term durability of the Nellix aneurysm sealing system.”
