CINCINNATI, Dec. 13, 2021 /PRNewswire/ -- Standard Bariatrics®, Inc. (SBI), a Cincinnati-based company focused on developing medical devices for surgical treatments of obesity, announced it reached a $1M sales milestone during November 2021 for the Titan SGS™, a surgical stapler first used in gastric sleeve surgery on August 24, 2021 following FDA clearance.
By working alongside bariatric surgeons, SBI is growing a portfolio of solutions with medical devices that meet bariatric surgeons' needs while delivering repeatable and consistent results. Bariatric surgeons across the country including California, Florida, Ohio, Kentucky, Alabama, Michigan, and North Carolina have used the Titan SGS since it was cleared by the FDA in April 20211.
The Titan SGS is designed to help surgeons achieve more consistent and symmetrical gastric sleeve pouch anatomy, setting patients up for the best possible outcomes. This first-of-its-kind design offers surgeons performing sleeve gastrectomy procedures the industry's longest continuous staple cutline of 23 centimeters². Surgeons can complete the sleeve pouch anatomy in a single firing² reducing the risk of anatomy variations associated with multiple, overlapping short-cartridge staple lines³.
In October 2021, the FDA issued new guidance on surgical staplers, which now fall under a Class II designation that includes guidelines for labeling regarding risks associated with staple line crossing. Titan SGS was cleared by the FDA under these more stringent Class II guidelines¹.
The first bariatric surgeon to use the Titan SGS was Aaron Hoffman, MD, FACS, Division Chief of General Surgery at the University of Buffalo (UBMD) Jacobs School of Medicine and Biomedical Sciences. Since this first use, surgeons are gaining confidence in the reproducibility of gastric sleeve anatomy from using Titan SGS.
Jon L. Schram, MD, board-certified physician specializing in bariatric surgery and weight loss management at Spectrum Health in Michigan had this to say about the Titan SGS technology: "Every sleeve looks just like the last… perfect! This is so much easier to teach and learn than expected. Because of COVID-19, we have been forced to move more of our sleeves to outpatient. Doing a better sleeve has made this very doable."
Gustavo Bello, MD, FACS from AdventHealth Medical Group Weight Loss and Bariatric Surgery at Orlando recently used the Titan SGS during sleeve gastrectomy cases and said, "The Titan SGS the sleeve anatomy now looks exactly like the pictures in the medical textbooks."
John Oldham, MD, Medical Director of Bariatrics for Baptist Health in Louisville, KY said, "In my 20 plus years of bariatric surgery, the Titan SGS is a game changer. Sleeves are amazing, exactly how you would want them to look." Prior to switching to the Titan SGS stapler, Dr. Oldham utilized the Standard Clamp® technology from Standard Bariatrics.
Surgeons interested in learning more about Titan SGS stapling technology or about applying for training and use can contact Ronald Galovich, Chief Commercial Officer of Standard Bariatrics. at 513.620.7751 or [email protected].
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 continues to release surgical solutions designed to address significant market opportunities. A seasoned team of medical and management professionals, Standard Bariatrics has more than 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 Series A lead investors RiverVest®, River Cities Capital, Hatteras Venture Partners and Emergent Medical Partners and more recently Series B investors U.S. Venture Partners (USVP).
For more information, visit https://www.standardbariatrics.com or call 513.620.7751.
- Indications for Use, K210278: "The Titan SGS linear cutter is intended for longitudinal transection and resection of gastric tissue for sleeve gastrectomy pouch creation."
- Goodman, Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection. 2020.
- Toro, Lin, Patel, et al. Association of Radiographic Morphology with Early Gastroesophageal Reflux Disease and Satiety Control after Sleeve Gastrectomy. Journal of American College of Surgeons. Sep: 219(3):430-8.2014.
SOURCE Standard Bariatrics
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