Released: 8/14/2020 11:25:36 AM
By Ellen Goldbaum
Release Date: August 13, 2020
BUFFALO, N.Y. – Standard Bariatric’s Titan SGS stapling technology, which features the longest continuous stapler cutline (23 centimeters), has been successful in an ongoing clinical trial at Buffalo General Medical Center, where the world’s first eight sleeve gastrectomy patients have been enrolled in the Investigational Device Exemption study. The University at Buffalo Department of Surgery reported the advancement today.
The clinical trial was a collaboration between surgeons led by Aaron B. Hoffman, MD, principal investigator, clinical associate professor and chief, Division of General Surgery in the Department of Surgery in the Jacobs School of Medicine and Biomedical Sciences at UB, Buffalo General Medical Center, where the surgeries were performed, and UB Research, Innovation, Structure, Simulation, Education and Engineering (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 FDA (U.S. Federal Drug Administration) clearance for clinical use,” said Steven Schwaitzberg, MD, professor and chair of surgery in the Jacobs School 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. Gastric sleeve is the predominant bariatric procedure in the world today and this key refinement will serve patients well for years to come.”
“Standard Bariatrics is honored that the team at UB performed this historic investigational device exemption study using our 23 cm longitudinal gastric stapler,” said Ronald Galovich, chief commercial officer at Standard Bariatrics. He predicts that this device will represent a significant step forward in gastric surgery stapling technology.
“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,” said Hoffman, who is also medical director of Kaleida Health’s Center for Minimally Invasive Surgery at Buffalo General.
“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,” said Hoffman, who is program director for UB’s 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 continued. “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 Kaleida Health’s Buffalo General Medical Center, 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.