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Standard Bariatrics’ Titan SGS Stapling Technology for LSG gains FDA approval

Tue, 05/04/2021 - 16:03
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Standard Bariatrics has announced that its novel Titan SGS stapling technology, designed specifically for bariatric sleeve surgery, has been cleared by the FDA.1 According to the company, the Titan SGS first-of-its-kind design offers surgeons performing sleeve gastrectomy procedures the industry’s longest continuous staple cutline of 23cms.2

Titan SGS was cleared after a successful 62-patient multi-centre 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 SGS.

“Gastric sleeve is the predominant bariatric procedure in the world today and this key refinement will serve patients well for years to come,” commented Dr Steven Schwaitzberg, professor and chair of surgery in the Jacobs School and president of UBMD Surgery.

“This clearance marks another important milestone in our mission to create solutions that can lead to more consistent and repeatable bariatric surgery outcomes,” said Dr Jonathan Thompson, Founder and Chief Medical Officer of Standard Bariatrics. “The Titan SGS stapling technology is the natural evolution of the Standard Clamp 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 SGS 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, the company claims.1,3,4 While every patient’s anatomy is different, the Titan SGS 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 23cm 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 SGS design may result in a more secure staple line and fewer chances of leaks, as evidenced with higher burst pressures.3 Because Titan SGS takes approximately half the time to create the staple line,6,7 it can also potentially improve procedure time and operational efficiencies.2,7

“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 SGS has the potential to overcome the challenges bariatric surgeons may encounter with the use of existing short-cartridge stapling technology.”

References

  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