Image: The Colovac endoluminal bypass sheath protects against anastomotic leakage (Photo courtesy of SafeHeal).
A new endoluminal bypass sheath could help surgeons avoid the need for a diverting ostomy in patients undergoing colectomy.
The SafeHeal (Paris, France) Colovac device is a seamless, minimally invasive, and fully reversible flexible bypass sheath that is intended to reduce any contact of fecal content with the colorectal anastomotic site, following open or laparoscopic colorectal surgery. It is anchored above the anastomosis using a stent combined with a vacuum-based mechanism; once in place, the implant covers the colon down to the anus, remaining in place until healing and tissue repair processes are complete, after which it is removed in an endoscopic procedure.
Colovac thus enables patients to resume their normal life without having to bear an artificial anus and wear ostomy pouches for several months. For the device’s European CE mark study, 15 colorectal surgery patients initially scheduled to receive a diverting ostomy will receive a Colovac device in lieu of the ostomy. The two first procedures were recently carried out at the Institute of Image-Guided Surgery (Strasbourg, France), in collaboration with CHU de Strasbourg (France).
“There is a high clinical and economic need for a disruptive product such as Colovac, which effectively reduces anastomotic leakage rates following colorectal surgery, while avoiding the distressing impacts of an ostomy for patients,” said Karl Blohm, CEO of SafeHeal. “This trial is a significant milestone in moving SafeHeal towards regulatory approval in Europe and the US.”
“In the two cases we performed, the Colovac procedure was very simple, safe and well received by the patients. We look forward to further participating in the clinical evaluation of this technology,” said digestive surgeon Antonio D’Urso, MD, principal investigator of the study. “Based on this early experience, the trial confirms the good usability of the device, its placement and retrieval, in line with preclinical experiments.”
Anastomotic leakage occurs in up to 20% of patients undergoing anterior resection. It is considered to be the most serious colorectal surgical complication, frequently resulting in the rapid development of severe peritonitis, septic shock, and multiple organ dysfunction. Ostomy, the current standard of care to reduce the risk of anastomotic leakage, is a traumatic and aggressive process that significantly reduces the quality of life of patients and entails its own complications.