Endologix's Nellix Shows Very Low Endoleak Rate in EVAS FORWARD–Global Registry

November 20, 2014—Endologix, Inc. announced the presentation of initial clinical data from the company's EVAS FORWARD—Global Registry, a postmarket study that prospectively enrolled patients with abdominal aortic aneurysms (AAA) who were treated with the Nellix endovascular aneurysm sealing (EVAS) system.

Andrew Holden, MD, presented the results at the 41st VEITHsymposium held November 18–22, 2014, in New York, New York. Dr. Holden, who serves as one of the principal investigators of the EVAS FORWARD—Global Registry, is Associate Professor of Radiology at Auckland City Hospital in Auckland, New Zealand. 

Endovascular Today had the opportunity to discuss the EVAS-FORWARD data with Dr. Holden while at the VEITHsymposium.

“The big promise of Nellix is that because it is an entirely new way of treating the aneurysm sac, we would not see complications—particularly endoleaks of any type—happening with the same incidence of other devices," commented Dr. Holden. "At 1 month, only two out of 289 (0.7%) patients had endoleaks, and that’s an absolutely incredible figure when we compare it to some of the data that we have from some of the other trials in terms of all types of endoleaks. Because there was no prospective screening, and no disqualification of patients whose anatomy was too challenging, this trial involves a much more challenging group of real world anatomies than other trial groups that have been there. Given that, it is remarkable that the results are so impressive in comparison to other trials.

“This device promised to be a paradigm shift in that you wouldn’t get endoleaks or migration; therefore, you wouldn’t get reintervention," continued Dr. Holden. "And, at least at 1 month and with a mean follow-up to 6 months, it looks like the promise is being met, and it’s a dramatic change compared to other devices. No one has been able to produce results like this.”

Key findings from the registry included: favorable median fluoroscopy times and procedure times were observed across the entire study group (11 and 98 minutes, respectively); in the early postoperative period, safety results are very positive with no device-related mortality; follow-up to 1 year indicated an overall endoleak rate of 1.1%; and overall device-related reintervention was 1.1%.

The EVAS FORWARD—Global Registry enrolled patients under a protocol having no anatomical restrictions, and representing a broad range of AAA anatomies. The study includes core lab assessment of computed tomography scans and independent physician adjudication of outcomes.

From October 2013 to September 2014, study investigators enrolled 300 patients treated with the Nellix EVAS system at centers in Europe and New Zealand. Patients enrolled in the EVAS FORWARD—Global Registry will be followed for 5 years, with primary endpoints evaluating safety and effectiveness of the Nellix EVAS system at 12 months postprocedure.

Dr. Holden reported that patients were enrolled with a broad range of aortic anatomies and a median AAA sac diameter of 6 cm. Additionally, 34% of patients enrolled in the registry were considered to be anatomically complex and difficult to treat with available endovascular repair devices. At this interim analysis, mean patient follow-up is 165 days; maximum follow-up is 1 year.

In his comments to Endovascular Today, Dr. Holden concluded, “I’ve been using the device right through since its early development. And it was certainly very rewarding to see results that support what I thought this device offers and what our local experience has indicated.”

Additional interim EVAS FORWARD—Global Registry data are expected to be presented during the 5-year follow-up period. The next data presentation from the registry is anticipated at the Charing Cross International Symposium in London, United Kingdom, on April 28 to May 1, 2015.

Endologix received European CE Mark approval for the Nellix EVAS system in the first quarter of 2013. In the United States, the device is only approved for investigational use. On November 18, the company announced that it has completed patient enrollment in the EVAS FORWARD-IDE clinical trial, the company’s United States pivotal clinical trial designed to evaluate the safety and effectiveness of the Nellix EVAS system for the endovascular repair of infrarenal AAAs.