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Product approval

Standard Clamp gains FDA indication for sleeve gastrectomy

The Standard Sleeve addresses issues of inconsistent surgical anatomy through an anatomy-based approach

Standard Bariatrics has received a sleeve gastrectomy indication from the FDA for the Standard Clamp. The Standard Sleeve addresses issues of inconsistent surgical anatomy through an anatomy-based approach, the company claims. Performed with the first-of-its-kind, purpose-built, disposable device, the Standard Clamp allows fixation of the full cut line across the entire stomach, enabling surgeons to plan and hold the staple line prior to dividing the stomach during sleeve gastrectomy.

“Standard Bariatrics is committed to creating superior bariatric surgery outcomes through device innovations. The acceptance of the supplemental data by the FDA to expand the U.S. indications of the Standard Clamp is another significant milestone for the Company,” said Jonathan Thompson MD, Founder and Chief Medical Officer of Standard Bariatrics. “With the patient’s health top priority, we aimed to standardize an anatomy-based approach to sleeve gastrectomy.”

Current techniques and device usage for laparoscopic sleeve gastrectomy are highly variable, and studies show that freehand sleeve gastrectomy techniques can yield inconsistent pouch anatomy. Because of challenges, bariatric surgeons have been able to achieve the ideal sleeve anatomy less than 40% of the time, resulting in inconsistent outcomes for the patient including reduced weight loss and GERD.2

 “The Standard Clamp allows planning, visualization and stabilization of the full staple line before staple firing, enabling bariatric surgeons to confidently achieve ideal surgical sleeve anatomy consistently,” said Ronald Galovich, Chief Commercial Officer of Standard Bariatrics. “We are excited about the opportunity to bring the Standard Clamp to every bariatric surgeon performing the sleeve gastrectomy procedure.”

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