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This article was originally published in The Gray Sheet

Executive Summary

BioEnterics subsidiary files PMA for its Lap-Band obesity treatment device Feb. 9 following completion of a 300-patient, eight-center clinical study with three-year follow-up. The device, which is comprised of a silicone elastomer band that can be inflated percutaneously with saline, can be placed laparoscopically around the upper part of the stomach, eliminating the need to cut, staple or bypass parts of the stomach or intestines, the firm claims
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