Sleeve gastrectomies are the most popular weight loss procedures in the U.S. right now, GastriSail co-developer Dr. Amit Trivedi of the Hackensack University Medical Center in N.J. told MassDevice.com.
Trivedi said he was inspired to create the device due to variability and ‘spiraling’ of gastric sleeves with current devices and methods.
“What I noticed when I was training residents, fellows and other surgeons was there was a tendency to spiral the stomach. Sometimes it came out twisted, you never really got a consistent sleeve when surgeons were cutting it, despite having a boogie – a rubber tube that serves as a guide. It just wasn’t working as well as I’d like,” Trivedi said.
The GastriSail reduces the number of tubes necessary for the procedure to just one, Trivedi said. The device suctions and evacuates the stomach and can automatically stretch it out to align the anterior and posterior walls and “remove any wrinkles” before dissection, Trivedi added.
The bariatric device also has LED lights to illuminate a set dissection line, Trivadi said, to aid in consistency of sleeve creation.
“The LED lights serve as basically a dotted line. Any surgeon with a reasonable skill set should be able to follow the dotted lines and cut right along them, and they’ll know how close or how far they are,” Trivadi said. “They’ll create a non-spiraled perfect sleeve every time, basically.”
After the procedure, the device can also perform a ‘leak test’, something commonly done with a separate device, Trivedi said.
In his use of the device, Trivadi said he’s seen reductions of 15 to 25 minutes for a procedure that normally takes between 1 hour or 1 hour and 15 minutes. Surgeons at Duke University, who are also using the device according to Trivadi, have reported similar time reductions.
“What it does is hopefully eliminates the potential for a spiral stomach because the anterior and posterior walls are perfectly aligned. That problem is under-diagnosed, you get patients with nausea, that just don’t feel right, and can’t get liquids down,” Trivadi said. “You worry whether the stomach has been spiraled or not, this eliminates that.”
The GastriSail received FDA 510(k) approval in February, the Fridley, Minn.-based medical giant said.
“The GastriSail system is a 1st-of-its-kind in the bariatric industry, and demonstrates our continued commitment to fight obesity with specialized solutions that provide better patient outcomes and have the potential to increase adoption of this well-established procedure. Working very closely with Dr. Trivedi, we were able to develop the GastriSail system as a unique solution that promotes consistency of the sleeve, but also procedural efficiency,” Medtronic senior veep and president of surgical innovations business, minimally invasive therapies group Chris Barry said in a press release.
The device is currently being launched in the U.S., Europe and the Middle East, with plans for global availability by the end of 2015, Medtronic said.