Published October 6, 2020
The Department of Surgery has reported that Titan SGS stapling technology from Standard Bariatrics Inc., which features the longest continuous stapler cutline (23 centimeters), has been successful in an ongoing clinical trial at Buffalo General Medical Center (BGMC).
The clinical trial features the world’s first eight sleeve gastrectomy patients who have been enrolled in an Investigational Device Exemption (IDE) study.
It is a collaboration between surgeons led by principal investigator Aaron B. Hoffman, MD, clinical associate professor of surgery and chief of the Division of General Surgery in the Jacobs School of Medicine and Biomedical Sciences, BGMC — where the surgeries were performed — and UB Research, Innovation, Structure, Simulation, Education and Engineering (UB RISE).
UB RISE is one of the nation’s largest full-service, noncommercial medical simulation centers with a breadth of training opportunities.
“We are thrilled that UB RISE and Dr. Hoffman’s research team were able to partner with Standard Bariatrics to perform the preclinical studies that led to U.S. Food and Drug Administration (FDA) clearance for clinical use,” says Steven D. Schwaitzberg, MD, professor and chair of surgery and president of UBMD Surgery.
“This first-in-the-world clinical use represents a true step forward in Buffalo’s continued drive to be a significant force in health care innovation,” he adds. “Gastric sleeve is the predominant bariatric procedure in the world today, and this key refinement will serve patients well for years to come.”
“Engineered specifically for gastric tissue, the Titan SGS has previously demonstrated superior staple formation and higher burst pressures in my preclinical investigations submitted to the FDA,” says Hoffman, who is also medical director of Kaleida Health’s Center for Minimally Invasive Surgery at BGMC.
“Now, the first eight sleeve gastrectomy IDE patients have shown that Titan SGS performed as designed during sleeve gastrectomy, and we have observed excellent hemostasis, sleeve shape and no leaks,” says Hoffman, who is program director for the Jacobs School’s advanced GI and minimally invasive surgery fellowship.
“The unique length of this gastric stapler appears to allow a more consistent and reproducible sleeve formation and eliminates any possibility of crossing of staple lines seen with current cartridge-based stapling technology,” he adds.
“Unlike cartridge-based, multi-fire general–use surgical staplers, the Titan SGS creates one continuous staple line during sleeve gastrectomy, which appears to result in more consistent sleeve morphology, fewer malformed staples and less bleeding by eliminating the crossed staple lines of traditional staplers.”
Following this first-ever surgical use at BGMC, Standard Bariatrics has embarked on further research in a small patient population at other sites to further validate the function and use of Titan SGS stapling technology.
“Standard Bariatrics is honored that the team at UB performed this historic investigational device exemption study using our 23cm longitudinal gastric stapler,” says Ronald Galovich, chief commercial officer at Standard Bariatrics, who predicts this device will represent a significant step forward in gastric surgery stapling technology.
Standard Bariatrics Inc., is a Cincinnati-based surgical procedure company focused on the innovative development and commercialization of medical devices for the surgical treatment of obesity.