SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

Aim: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD.

Evaluation of the SafeHeal Colovac+ anastomosis protection device after low anterior resection for rectal cancer: the safe anastomosis feasibility evaluation (SAFE) 2019 trial.

Background: Protective ileostomy (PI) is the current standard of care to protect the anastomosis after low anterior resection (LAR) for rectal cancer, but is associated with significant morbidity. Colovac is an anastomosis protection device designed to shield the anastomosis from fecal content. A second version (Colovac+) was developed to limit the migration risk during the implantation period.

Metastatic melanoma causing small intestinal perforation at the jejunojejunostomy after Roux-en-Y gastric bypass: a case report.

Background: Metastatic melanoma of the small intestine is relatively common, and among affected patients, the proportion with involvement of the small intestine ranges from 35% to 70%. Small intestinal perforation as a primary manifestation of metastatic melanoma is rare. We present the exceptional case of a perforation at the jejunojejunostomy after Roux-en-Y gastric bypass caused by metastatic melanoma.

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.

Symptomatic arterial thrombosis associated with novel coronavirus disease 2019 (COVID-19): report of two cases.

Since December 2019, the outbreak of the novel coronavirus disease (COVID-19) in China has rapidly spread throughout the world. During the course of the COVID-19 pandemic, thrombotic complications have emerged as an important issue. We present two cases of symptomatic arterial thrombosis in patients with confirmed COVID-19.