Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support

In accordance with a revised data analysis plan approved under the IDE , 6 patients were excluded from the hypothesis testing due to meeting certain medical exclusion criteria (i.e., patients who were ASA class V or who were without confirmed absence of bowel necrosis at the time of enrollment).Additional information/reference why no analysis was performed for 6 patients is listed in the CIP in section 7.1

Primary effectiveness endpoint is freedom from all cause mortality at 30 days

In accordance with a revised data analysis plan approved under the IDE , 6 patients were excluded from the hypothesis testing due to meeting certain medical exclusion criteria (i.e., patients who were ASA class V or who were without confirmed absence of bowel necrosis at the time of enrollment). Additional information/reference why no analysis was performed for 6 patients is listed in the CIP in section 7.1