Endologix announced on 18 November 2014 that it has completed patient enrolment in the EVAS FORWARD-IDE clinical trial, the company’s US pivotal clinical trial designed to evaluate the safety and effectiveness of the Nellix EndoVascular Aneurysm Sealing System (Nellix EVAS System) for the endovascular repair of infrarenal abdominal aortic aneurysms.
The primary endpoint analysis results at one-year and beyond will be used to support the company’s premarket approval (PMA) application to the FDA for the Nellix EVAS System.
Jeffrey Carpenter, professor and chairman of Surgery for Cooper Medical School and Chief of Surgery for Cooper Health System in New Jersey, and national principal investigator of the EVAS FORWARD-IDE clinical trial, stated, “The Nellix IDE clinical trial is the first study to examine the safety and effectiveness of EVAS in patients in the United States. Nellix has the potential to be a breakthrough technology for the treatment of abdominal aortic aneurysms because it is the only device that directly targets the primary cause of secondary interventions by sealing the entire aneurysm sac. We look forward to monitoring the trial patients during the follow-up period and remain optimistic that Nellix will improve patient outcomes and enable physicians to treat more patients in the future.”
The EVAS FORWARD-IDE clinical trial enrolled 179 patients at 29 centres in the USA and Europe. Enrolment under an extended investigation phase is anticipated to begin shortly and will continue during the pivotal trial follow-up period and PMA preparation/review process. Based on current assumptions and timelines, the company anticipates FDA approval of the Nellix System in the USA before the end of 2016.
Robert Cuff, a vascular surgeon with Spectrum Health in Grand Rapids, USA, and leading enroller in the Nellix pivotal trial said, “EVAS with Nellix holds the promise of being a significant advancement in the treatment of abdominal aortic aneurysms. In the cases performed at our site, we found the Nellix procedure to be simple, predictable and with good acute outcomes. Based upon our results so far, we expect that Nellix will significantly reduce endoleaks and provide meaningful clinical benefits for patients. We look forward to participating in the Continued Access phase of the IDE and offering Nellix to patients when it is commercially available in the USA.”
John McDermott, chairman and chief executive officer of Endologix, said, “The completion of enrolment in the Nellix pivotal trial is another important milestone as we work to bring this groundbreaking technology to patients in the USA. We are already experiencing strong adoption of Nellix in Europe and the physician enthusiasm in the USA is equally positive, giving us confidence in the long-term potential of EVAS with Nellix to be an important new solution for patients with abdominal aortic aneurysms.”
The Nellix EVAS system is a new generation of abdominal aortic aneurysm therapy designed to seal the entire aneurysm and improve patient outcomes. Nellix is the first and only EVAS device and was developed to simplify procedures, minimise endoleaks, reduce reinterventions and expand the treatable patient population. Endologix received the CE mark for the Nellix EVAS System in the first quarter of 2013 and the commercial introduction of the product in Europe is currently underway. The Nelllix EVAS System is approved for clinical trial use only in the USA and is not approved in the USA for commercial use.