USGI Medical to launch pivotal U.S. study of incisionless, endoscopic weight loss procedure

California's USGI Medical said the FDA gave conditional investigational device exemption (IDE) approval to begin enrolling approximately 350 patients in a pivotal study of an incisionless, endoscopic weight loss procedure. Participating patients will use the company's g-Cath EZ Suture Anchor Delivery Catheter to place tissue anchors across folds of tissue in certain parts of the stomach in order to reduce its size and ability to stretch to accommodate a meal. Surgeons have already performed the incisionless, outpatient procedure on more than 2,000 patients, mostly in Europe, working through the mouth. Patients return to work, bandage-free, within two to three days. The study will take place at up to 9 U.S. centers and be randomized and sham-controlled. Item

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