Standard Bariatrics® announced today that its novel Titan SGS™ stapling technology, designed specifically for bariatric sleeve surgery, has been cleared by the US Food and Drug Administration (FDA).
1 The Titan SGS™ 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 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.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 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 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
Titan SGS™ 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 SGS™. 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 SGS™ has the potential to overcome the challenges bariatric surgeons may encounter with the use of existing short-cartridge stapling technology."