Subject: FDA
Standard Bariatrics® Titan SGS Stapling Technology for Sleeve Gastrectomy Receives FDA Clearance
CINCINNATI, May 4, 2021 /PRNewswire/ -- Standard Bariatrics® announced today that its novel Titan SGStm stapling technology, designed specifically for bariatric sleeve surgery, has been cleared by the US Food and Drug Administration (FDA).1 The Titan SGStm first-of-its-kind design offers surgeons performing sleeve gastrectomy procedures the industry's longest continuous staple cutline of 23 centimeters.2
"This clearance marks another important milestone in our mission to create solutions that can lead to more consistent and repeatable bariatric surgery outcomes," said Jonathan Thompson, MD, Founder and Chief Medical Officer of Standard Bariatrics®. "The Titan SGStm stapling technology is the natural evolution of the Standard Clamptm anatomy-based approach to sleeve gastrectomy, which has been successfully used in more than 10,000 procedures."
With a purposeful design, driven by the needs of today's bariatric surgeon performing sleeve gastrectomy, Titan SGStm provides real-time audio and visual feedback, graduated staple height formation, tissue-sensing technology and a firing cycle optimized particularly for the patient's gastric tissue during gastrectomy pouch creation.1,3,4 While every patient's anatomy is different, the Titan SGStm long staple line enables surgeons to plan and place staples in one firing, minimizing variations often associated with the current use of multiple overlapping short-cartridge staple firings.5
The design ensures more consistent staple formation across the entire 23-centimeter cutline for improved staple-line strength and fewer malformed staples than competitive staplers that offer short cartridges for more general surgical use.2,3,4 The Titan SGStm design may result in a more secure staple line and fewer chances of leaks, as evidenced with higher burst pressures.3 Because Titan SGStm takes approximately half the time to create the staple line,6,7 it can also potentially improve procedure time and operational efficiencies.2,7
Titan SGStm was cleared after a successful 62-patient multi-center trial in longitudinal gastric stapling.2 The University of Buffalo Department of Surgery in the Jacobs School of Medicine and Biomedical Sciences (UBMD) was the first to use Titan SGStm. Steven Schwaitzberg, MD, professor and chair of surgery in the Jacobs School and president of UBMD Surgery said, "Gastric sleeve is the predominant bariatric procedure in the world today and this key refinement will serve patients well for years to come."
"We are focused on bringing innovation and breakthroughs in science and surgery to our users," said Matt Sokany, Chief Executive Officer of Standard Bariatrics®. "We believe Titan SGStm has the potential to overcome the challenges bariatric surgeons may encounter with the use of existing short-cartridge stapling technology."
Surgeons interested in learning more about Titan SGStm 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 more recently Series A lead investors RiverVest®, Hatteras Venture Partners and Emergent Medical Partners.
For more information, visit http://www.standardbariatrics.com or call 513-620-7751.
1. Indications for Use, K210278: "The Titan SGS linear cutter is intended for longitudinal transection and resection of gastric tissue for sleeve gastrectomy pouch creation."
2. Goodman, Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection.2020
3. Slayer, Spuzzillo, Wakefield, et al. Assessment of a novel stapler performance for laparoscopic sleeve gastrectomy.2020
4. Yeo, Thompson, Hanseman, Diwan, Dunki-Jacobs, et al. Increased staple loading pressures and reduced staple heights in laparoscopic sleeve gastrectomy reduce intraoperative bleeding.2020
5. Toro, Lin, Patel, et al. Association of Radiographic Morphology with Early Gastroesophageal Reflux Disease and Satiety Control after Sleeve Gastrectomy.2014
6. Titan Pre-clinical 510K data on file
7. Varban, Niemann, Stricklen, et al. Far from Standardized. Journal of Laparoendoscopic & Advanced Surgical techniques.2107
Media Contact
Ronald Galovich
Chief Commercial Officer, Standard Bariatrics®
513.620.7751
[email protected]
SOURCE Standard Bariatrics
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