Author(s): Matthew Burstein, MD and Aaron Hoffman, MD
Standard Bariatrics received FDA clearance for the Titan SGS on April 28th, 2021 (K210278).
The Titan SGS with implantable staples is a single patient use, laparoscopic sterile powered linear stapler used for cutting and stapling gastric tissue during sleeve gastrectomy. The stapler end effector is 230 mm long and contains 342 staples that are organized in 6 staggered rows, 3 on each side of the cut line. The staples range in closed staple height from 2.2 mm to 1.2 mm to match gastric tissue thickness. The Titan Stapler is used for an “anatomic” sleeve gastrectomy where the pylorus, incisura angularis, and Angle of His are used as landmarks.
A single-site comparative clinical study with 36 subjects compared the Titan Stapler and the predicate device, on excised human stomach (NCT04086433). Results demonstrated substantially equivalent performance between the two devices.
An additional multi-site study enrolled 62 subjects undergoing sleeve gastrectomy alone or as part of duodenal switch (NCT04347837). Results demonstrated that the Titan SGS stapler provided reasonable assurance of safety and effectiveness to demonstrate substantial equivalence.
The FDA has determined that this device is substantially equivalent to a predicate device, the Echelon Flex Powered Plus (K140560) which uses a linear powered stapler, a reloadable 30 – 60 mm jaw, and a cutting blade with three staggered rows of titanium staples on each side of the cut line. The staples are of set height throughout the length of the predicate device.
The Titan SGS linear cutter is intended for longitudinal transection and resection of gastric tissue for sleeve gastrectomy creation.
The Titan SGS linear cutter is not intended for use on non-gastric tissue.