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Weight loss: USGI launches ambitious study of incision-free bariatric surgery

Fri, 10/11/2013 - 11:29am
Mass Device

California weight-loss surgery systems maker USGI Medical lands FDA approval to launch what may be the largest pivotal study of its kind for an endoscopic weight-loss procedure.

Weigh loss: USGI launches ambitious study of incision-free bariatric surgery system

USGI Medical will enroll up to 350 patients in an FDA-approved clinical trial of the g-Cath EZ suture anchor delivery catheter, an incision-free bariatric surgery technology that has already been used on more than 2,000 patients, mostly in Europe.

The San Clemente, Calif.-based device maker won conditional FDA investigational device exemption to launch the study, which USGI "believes to be the largest multi-center, randomized, sham-controlled study of an endoscopic procedure for weight loss ever conducted."

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