The Titan SGS long staple line allows surgeons to plan and place staples in one firing
The FDA has approved Standard Bariatrics’ Titan SGS stapling technology for sleeve gastrectomy. (Credit: Standard Bariatrics. Inc.)
Cincinnati-based surgical procedure firm Standard Bariatrics has secured approval from the US Food and Drug Administration (FDA) for its novel Titan SGS stapling technology for use in bariatric sleeve surgery.
Claimed to be the first-of-its-kind, the Titan SGS system will enable surgeons to conduct sleeve gastrectomy procedures with the longest continuous staple cutline of 23cm.
Standard Bariatrics founder and chief medical officer Jonathan Thompson said: “This clearance marks another important milestone in our mission to create solutions that can lead to more consistent and repeatable bariatric surgery outcomes.”
The FDA has approved the Titan SGS system based on data from the 62-patient multi-centre trial in longitudinal gastric stapling.
Standard Bariatrics founder and chief medical officer Dr Jonathan Thompson said: “This clearance marks another important milestone in our mission to create solutions that can lead to more consistent and repeatable bariatric surgery outcomes.”
“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.”
Titan SGS system has been designed to offer real-time audio and visual feedback, graduated staple height formation and tissue-sensing technology, as well as a firing cycle optimised specifically for the patient’s gastric tissue during gastrectomy pouch creation.
Standard Bariatrics’ Titan SGS long staple line allows surgeons to plan and place staples in one firing, thereby helping to reduce variations generally associated with the current use of multiple overlapping short-cartridge staple firings.
According to the company, the design ensures more consistent staple formation across the entire 23cm cutline for enhanced staple-line strength and fewer malformed staples than competitive staplers that offer short cartridges for more general surgical use.
The system also helps in providing a more secure staple line and minimising chances of leaks, said the company.
The University of Buffalo Department of Surgery in the Jacobs School of Medicine and Biomedical Sciences (UBMD) was the first to use Titan SGS stapling technology, stated Standard Bariatrics.