Safety
constipation
VITAMIN D DEFICIENCY
In continuity with the perioperative period, there were no device-related AEs or SAEs and no mortality through study end. Ten additional procedure-related AEs accrued between day 31 and 360: 3 patients tested positive for COVID-19 which resolved (CDC grade I); 1 patient experienced constipation near day 360 which was effectively treated with standard medication (CDC grade II); 1 patient had a vitamin D deficiency which resolved with supplementation (CDC grade II); and at ≥ 180 days, 5 patients who entered the study with normal vitamin B