Early Commercial Experience Reported for Endologix Nellix EVAS System

May 12, 2015—Dittmar Böckler, MD, et al published findings from a multicenter postmarket experience with the Nellix endovascular aneurysm sealing (EVAS) system (Endologix, Inc.). The study is available online ahead of print in the Journal of Vascular Surgery (JVS).

In JVS, the investigators concluded that the Nellix device for infrarenal abdominal aortic aneurysm repair demonstrates satisfactory results during the initial learning phase of this new technology, with a high rate of aneurysm exclusion and low frequency of complications. More definitive conclusions will be obtained in the company’s ongoing postmarket EVAS FORWARD global registry and the EVAS FORWARD investigational device exemption trial, advised the investigators. 

On April 29, Endologix announced that updated clinical data from the EVAS FORWARD global registry were presented by Professor Matt Thompson, MD, at the Charing Cross Symposium in London, United Kingdom.

The investigators of the current study noted in JVS that the Nellix device employs a unique design with deployment of polymer-filled EndoBags surrounding the endograft flow lumens, sealing the aneurysm sac space and potentially reducing complications from persistent sac flow. 

As summarized in JVS, this retrospective analysis represents the initial experience in consecutive patients treated with the device in real-world practice at six clinical centers in Europe and one in New Zealand during the initial period after commercialization of the Nellix device. Patients underwent evaluation with CT and other imaging modalities following local standards of care. Patients were selected for treatment with Nellix and treated by each institution according to its endovascular repair protocol. 

Clinical and imaging endpoints included technical success (successful device deployment and absence of any endoleak on completion angiography), freedom from all-cause and aneurysm-related mortality, endoleak by type, limb occlusion, aneurysm rupture, and reintervention.

During a 17-month period, 171 patients with abdominal aortic aneurysms were treated with the Nellix device and observed for a median of 5 months (range, 0–14 months). The 153 male and 18 female patients with mean age of 74 ± 7 years had aneurysms 61 ± 9 mm in diameter with an average infrarenal neck length of 28 ± 15 mm and infrarenal angulation of 37° ± 22°. Technical success was achieved in all but two patients (99%); one patient had a type Ib endoleak and another had a type II endoleak. 

Through the last available follow-up, type Ia endoleak was observed in five patients (3%), type Ib endoleak in four patients (2%), and type II endoleak in four patients (2%). There were eight limb occlusions (5%), among which, seven were evident at the 1-month follow-up visit. Aneurysm-related reinterventions were performed in 15 patients (9%). There were no aneurysm ruptures or open surgical conversions, reported the investigators in JVS.