Evaluation of the SafeHeal Colovac+ Anastomosis Protection Device: A Preclinical Study.

BackgroundThe protective ostomy is the current standard of care to protect a low colorectal anastomosis from leakage, but exposes patients to complications requiring an alternative strategy. The Colovac+ is a vacuum-based intraluminal bypass device designed to shield the anastomosis from fecal content, preventing the clinical outcomes of anastomotic leakage. The objective of this study was to evaluate the preliminary efficacy, safety, and technical feasibility of the Colovac+ in a porcine model.

Assessment of a Vacuum-Based Intra-Colonic Diverting Device: A Preclinical Study.

. Anastomotic leak is the main complication after low colorectal anastomosis. Defunctioning ileostomy is therefore recommended, which carries its own morbidity.