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SafeHeal Set To Bring Colovac Colonic Bypass Sheath Into Clinical Trials

 
• By Reed Miller

SafeHeal, a collaboration between an inventor-surgeon and Paris-based medtech accelerator MD Start, has enough funding to achieve a CE mark, and is looking for a partner to help it earn a 510(k) from US FDA.

3d render illustration of human digestive system - front view
• Source: shutterstock.com

The first-in-man trials of SafeHeal Medical’s Colovac, a colonic anastomosis protection device designed to obviate the need for diverting ostomies in patients undergoing colectomy, will begin enrolling patients in Europe by the end of 2016, according to CEO Anne Osdoit.

The safety and feasibility of Colovac, invented by digestive surgeon Charam Khosrovani in Sorgues, France, has been established in pre-clinical trials in 90 pigs, including a randomized pig study, Osdoit...

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