Endologix has announced positive clinical data from the Italian Research Nellix Endoprosthesis (IRENE) study at the 2016 Society of Vascular Surgery (SVS) annual meeting (8–10 June, New Harbor, USA). This retrospective, multicentre study was designed to evaluate the Nellix EndoVascular Aneurysm Sealing (EVAS) system for the endovascular repair of infrarenal abdominal aortic aneurysms.
The key highlights from the IRENE study clinical data include:
- 335 consecutive elective patients were enrolled at 16 centres throughout Italy from September 2013–November 2015; 244 patients reached one-year follow-up
- 88% of the patients were treated within the device instructions for use, with 100% procedural technical success achieved
- Low all-cause mortality of 0.9%
- 2.4% overall incident endoleak
- 0.9% limb occlusion
- 4.4% secondary interventions
- No ruptures and no migration.
Bruno Gossetti, University of Rome La Sapienza, Rome, Italy, and principal investigator of the IRENE study, said, “We are very pleased with the initial procedural results and outcomes using Nellix in Italy in a wide range abdominal aortic aneurysm anatomies in a non-selected population and within high instructions for use compliance. The low endoleak, graft occlusion, and aneurysm-related reintervention rates are very encouraging.” Fabio Verzini, University of Perugia, Perugia, Italy and IRENE investigator presented these data at the SVS meeting, where he commented, “These data support the adoption of EVAS with Nellix in the real-world setting, including in patients who are more susceptible to type II endoleaks.”
John McDermott, Chairman and Chief Executive Officer of Endologix, said, “The results from IRENE are consistent with the EVAS FORWARD Global Registry and the recently reported EVAS FORWARD IDE study, demonstrating a low rate of endoleaks and secondary interventions in a large population of real-world abdominal aortic aneurysm patients. We look forward to our continued collaboration with physicians worldwide to provide innovative and durable solutions for patients with abdominal aortic aneurysms.”