Data from the EVAS FORWARD-IDE (investigational device exemption) study released on 26 May 2016 demonstrate that the Nellix EndoVascular Aneurysm Sealing System (Nellix EVAS System) EVAS System (Endologix) met the study primary endpoints for major adverse events at 30 days (safety) and treatment success at one year (effectiveness).
EVAS FORWARD-IDE is a multicentre, prospective, single-arm clinical study designed to evaluate the safety and effectiveness of the Nellix for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).
The key highlights from the EVAS FORWARD-IDE study clinical data include:
- 150 patients in the pivotal cohort were treated at 30 centres in the USA and Europe between January and November 2014.
- 100% procedural technical success achieved.
- The major adverse event rate at 30 days was 2.7%, achieving the primary safety endpoint and comparing positively to the Society for Vascular Surgery (SVS) open surgical repair control group rate of <56%.
- At one year, the treatment success rate was 94%, achieving the primary effectiveness endpoint and comparing favourably to the performance goal of >80%.
- Freedom from all-cause mortality and aneurysm-related mortality were 96% and 99% respectively.
- Freedom from device-related secondary interventions was 96.6%, the highest rate ever reported for an IDE study of an endovascular abdominal aortic aneurysm device.
- Endoleaks were present in 3.1% of patients at one year, the lowest rate ever reported for an IDE study of an endovascular abdominal aortic aneurysm device.
Jeffrey P Carpenter, professor and chairman of Surgery for Cooper Medical School and chief of Surgery for Cooper Health System, New Jersey, USA, and National Principal Investigator of the EVAS FORWARD-IDE clinical study, said, “We are very pleased to report that the EVAS FORWARD-IDE study met its primary safety and effectiveness endpoints. The one-year results are highly encouraging and demonstrate that low overall endoleaks can reduce secondary interventions. This is an important milestone towards achieving FDA approval and making the Nellix aneurysm sealing technology available to AAA patients in the United States.”
The Nellix EVAS System is a new generation of abdominal aortic aneurysm therapy designed to seal the entire abdominal aortic aneurysm sac. It is the first and only EVAS product and was developed to reduce all types of endoleaks and improve long-term patient outcomes. Nellix is an investigational device in the United States.
The results from the EVAS FORWARD-IDE Study were submitted to the US Food and Drug Administration as part of the company’s premarket approval submission for Nellix EVAS System. The company remains on track to receive potential FDA approval for the Nellix EVAS System at the end of 2016 or early 2017.
The positive clinical data from the EVAS FORWARD-IDE Study has been published in the schedule of the upcoming 2016 Vascular Annual Meeting of the Society for Vascular Surgery (SVS), which is taking place from 8–11 June 2016 in National Harbor, USA. Carpenter will present the full results from EVAS FORWARD-IDE study on the morning of Saturday, 11 June.