Innovative laparoscopic bariatric device manufacturer announces FDA 510(k) clearance for Sleeve Gastrectomy
Cincinnati, Ohio – October 22, 2018 – Standard Bariatrics, an innovator of surgical devices, has received a sleeve gastrectomy indication from the Food and Drug Administration (FDA) for the STANDARD CLAMP®.1
“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 SLEEVE™ addresses issues of inconsistent surgical anatomy through an anatomy-based approach. 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.
“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.”
About Standard Bariatrics, Inc.
Standard Bariatrics, Inc., is a Cincinnati-based surgical procedure company focused on the innovative development and commercialization of medical devices. Driven by a passionate group of surgical innovators, the company will continue to release surgical solutions designed to address significant market opportunities. The Standard Bariatrics management team has over 175 combined years of experience in developing and commercializing novel medical device technologies with a record of achieving both clinical and economic excellence for patients and providers.
Standard Bariatrics is supported through early investment from Queen City Angels and CincyTech, and more recently Series A lead investors RiverVest® and Hatteras Funds. For more information, visit https://www.standardbariatrics.com or call 513-620-7751.
Ronald Galovich, Chief Commercial Officer
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1 K181608 The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.
2 Toro, JP, et al. (2014). Association of radiographic morphology with early gastroesophageal reflux disease and satiety control after sleeve gastrectomy. Journal of American College of Surgeons. Sep; 219(3):430-8.