SafeHeal recently announced that it has won CE Mark approval for its Colovac bypass sheath.
Colovac is an endoluminal bypass sheath that is placed in the colon after colorectal resection. It is designed to suppress contact of fecal content with the colorectal anastomotic site to improve patient recovery and without the need for an ostomy.
The bypass sheath is minimally invasive and fully reversible. It is able to remain in place until the body’s natural healing and tissue repair processes are finished. It is easily removed through an endoscopic procedure.
“Obtaining the CE mark is a significant achievement and an important milestone for SafeHeal. This clearly indicates that Colovac meets the essential requirements for product safety, performance and usability, in compliance with the latest rigorous requirements set by EU regulations,” Karl Blohm, CEO of SafeHeal, said in a press release. “We are now looking forward to further clinical validation, especially with the initiation of our FDA study.”
SafeHeal’s Colovac device is attached above the anastomosis using a stent and a vacuum-based mechanism. The implant covers the colon down to the anus and can be removed without a second surgical intervention.