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Ostomy Pouch Articles & Analysis: Older

4 news found

SafeHeal obtains CE-mark for Colovac, its novel endoluminal bypass sheath

SafeHeal obtains CE-mark for Colovac, its novel endoluminal bypass sheath

At the end of 2018, SafeHeal concluded its successful first-in-human clinical study in fifteen patients, with results demonstrating that Colovac can successfully obviate the need for a diverting ostomy for the majority of patients undergoing colorectal surgery. ...

BySafeHeal


SafeHeal Completes First-in-Human Clinical Study of Endoluminal Bypass Sheath

SafeHeal Completes First-in-Human Clinical Study of Endoluminal Bypass Sheath

The single-arm 15-patient study was aimed at evaluating the safety and efficacy of Colovac in the protection of colorectal anastomosis in adult patients who were scheduled to receive a diverting ostomy, following colorectal surgery. During the study phase, patients received a Colovac implant for two weeks, in place of a diverting ostomy. ...

BySafeHeal


SafeHeal closes €6.0 million financing round led by Sofinnova Partners

SafeHeal closes €6.0 million financing round led by Sofinnova Partners

SafeHeal’s device has the potential to radically transform the market while significantly improve patients’ quality of life by enabling them to resume their normal life without having to bear an artificial anus and wear ostomy pouches for several months. About 270,000 colectomy patients receive an ostomy every year in Europe and the ...

BySafeHeal


SAFEHEAL starts first-in-human and CE-mark clinical study of endoluminal bypass sheath with the potential of replacing ostomy

SAFEHEAL starts first-in-human and CE-mark clinical study of endoluminal bypass sheath with the potential of replacing ostomy

It aims to evaluate the safety and efficacy of Colovac for the protection of colorectal anastomosis in adult patients initially scheduled to receive a diverting ostomy as per standard of care, following colorectal surgery. In the study, patients receive a Colovac device in lieu of the ostomy. ...

BySafeHeal

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