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SafeHeal wins CE Mark approval for bypass sheath

April 12, 2019 By Danielle Kirsh

safeheal-logoSafeHeal 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.

About The Author

Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

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