Endologix, developer of minimally invasive treatments for aortic disorders, announced the publication of favorable clinical results of the Nellix technology for the endovascular repair of abdominal aortic aneurysm (EVAR). The peer-reviewed article, published in the February issue of the Journal of Vascular Surgery (JVS), reported initial results from the international multicentre clinical trial, with successful aneurysm exclusion in all patients, and no late aneurysm or device-related adverse events or secondary procedures.
Carlos E. Donayre, lead author and scientific advisor, Harbor-UCLA Medical Center, Torrance, USA, commented: “The Nellix technology was designed to address the limitations of currently available EVAR devices and to expand the therapy to more patients. By filling the aneurysm sac, the Nellix device may reduce the incidence of endoleaks, secondary interventions and the need for annual CT scan follow-up.”
The Nellix endoprosthesis consists of dual balloon-expandable endoframes surrounded by polymer-filled endobags designed to obliterate the aneurysm sac and maintain endograft position, features that help to address the anatomic restrictions and limitations of current endografts.
The study, entitled “Initial clinical experience with a sac anchoring endoprosthesis for aortic aneurysm repair,” examined the initial and one year outcomes of 21 patients treated at four international centres. An independent core laboratory analysed pre-operative and post-procedural computed tomography scans to determine aneurysm exclusion and device stability over time.
John McDermott, president and CEO, Endologix, said, “We believe the Nellix technology represents the next generation in endovascular repair of abdominal aortic aneurysms. Since completing the acquisition in December 2010, we are delighted that initial results of the international trial are now published by a peer review journal and we look forward to providing the clinical community with updates as more data is available. In addition to Nellix, our Ventana fenestrated stent graft and AFX system continue to advance on schedule. We believe this robust new product pipeline will enable us to expand the EVAR market.”
The endograft was successfully deployed in 21 patients with infrarenal aortic aneurysms measuring 5.7 ± 0.7 cm (range, 4.3-7.4 cm). Two patients with common iliac aneurysms were treated with sac-anchoring extenders that maintained patency of the internal iliac artery. Infusion of 71 ± 37mL of polymer (range, 19-158mL) into the aortic endobags resulted in complete aneurysm exclusion in all patients.
Mean implant time was 76 ± 35 minutes, with 33 ± 17 minutes of fluoroscopy time and 180 ± 81mL of contrast; estimated blood loss was 174 ± 116mL. One patient died during the postoperative period (30-day mortality, 4.8%), and one died at 10 months from non-device-related causes. During a mean follow-up of 8.7 ± 3.1 months and a median of 6.3 months, there were no late aneurysm-or device-related adverse events and no secondary procedures. CT imaging studies at 6 months and 1 year revealed no increase in aneurysm size, no device migration, and no new endoleaks. One patient had a limited proximal type I endoleak at 30 days that resolved at 60 days and remained sealed. One patient has an ongoing distal type I endoleak near the iliac bifurcation, with no change in aneurysm size at 12 months.