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Colorectal Anastomotic Articles & Analysis

7 news found

SafeHeal appoints medical device industry veteran Chris Richardson as Chief Executive Officer

SafeHeal appoints medical device industry veteran Chris Richardson as Chief Executive Officer

The company develops the Colovac device, designed to eliminate the need for diverting ostomies post Colorectal cancer resection. SafeHeal announced in April 2022 the first patient enrollment in its US pivotal study of Colovac, (SAFE 2) with as many as 20 U.S. and European sites enrolling patients in the study. ...

BySafeHeal


SafeHeal Announces Successful Launch of IDE Study for Colovac Endoluminal Bypass Sheath

SafeHeal Announces Successful Launch of IDE Study for Colovac Endoluminal Bypass Sheath

” The SAFE-2 randomized controlled IDE study will assess the safety and efficacy of the Colovac endoluminal bypass sheath in adult patients who were initially scheduled to receive a diverting ostomy following colorectal surgery. Diverting ostomy, the current standard of care, is applied prophylactically to most patients today undergoing a low anterior resection (LAR) and ...

BySafeHeal


SafeHeal closes €40 million financing co-led by Sofinnova Partners and Genesis MedTech to finance its Colovac device through a pivotal clinical trial in the United States

SafeHeal closes €40 million financing co-led by Sofinnova Partners and Genesis MedTech to finance its Colovac device through a pivotal clinical trial in the United States

The Colovac solution addresses the most serious complication of colorectal surgery - anastomotic leakage, the leaking of fecal content in the abdominal cavity, which can lead to sepsis or even death. ...

BySafeHeal


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

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

Colovac is a unique endoluminal bypass sheath placed in the colon following colorectal resection. It suppresses the contact of fecal content with the colorectal anastomotic site in order to significantly improve patient recovery after colorectal surgery, without the need for an ostomy. ...

BySafeHeal


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

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

Jérémie Lefevre, M.D., Ph.D., professor of General Surgery, colorectal surgeon at Saint Antoine Hospital The Colovac device is a unique endoluminal bypass sheath placed in the colon following rectal resection, aimed at suppressing contact of fecal content with the colorectal anastomotic site. ...

BySafeHeal


SafeHeal closes €6.0 million financing round led by Sofinnova Partners

SafeHeal closes €6.0 million financing round led by Sofinnova Partners

This financing round allows them to engage in the transformation from incubation status to commercial operations”Anne Osdoit, Partner at MD Start and co-founder of SafeHeal “We are excited to invest in SafeHeal and believe that their endoluminal bypass sheath is the most innovative disruption in the protection of colorectal anastomosis. This investment also ...

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. ...

BySafeHeal

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