The key highlights from the EVAS FORWARD-IDE study clinical data include:
- 150 patients in the pivotal cohort were treated at 30 centers in the US and Europe between January and November 2014.
- 100% procedural technical success achieved.
- The major adverse event (MAE) 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 favorably to the performance goal of > 80%.
- Freedom from all-cause mortality and AAA-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 AAA device.
- Endoleaks were present in 3.1% of patients at 1-year, the lowest rate ever reported for an IDE study of an endovascular AAA device.
