Patient assessments
ADVERSE EVENTS
All enrolled participants had a preprocedural study visit for assessment of their demographics and relevant medical history. After the index procedure, participants were evaluated in person or by telephone at 72 hours (−1 day to + 2 days) and again at 30 days (± 3 days) to screen for post-procedure adverse events (AEs) or resolution of any previously reported issues. If the last follow-up visit was not completed, the reason was noted on the study completion form. Participants were considered lost to follow-up if they failed to return for their scheduled follow-up visits and were unable to be contacted by the study site staff after at least three documented attempts.