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. 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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