Standard Bariatrics® Announces the First Post-FDA-Clearance Use of Titan SGS™
Bariatric surgeon Aaron Hoffman, MD, FACS, this week completed the first procedures using Titan SGS™ following its clearance by the FDA in April 2021. Dr. Hoffman performed five cases. The Titan SGS was cleared for use after a multi-site, 62-patient IDE study in longitudinal gastric resection. The nonclinical and clinical tests demonstrated that Titan SGS is as safe and as effective and performs as well as or better than current marketed devices. (Goodman: Salyer, C. E., Thompson, J., Hoffman, A., Burstein, M. D., Enochs, P., Watkins, B. M., Kuethe, J., & Goodman, M. D. (2022). Multisite Study of Titan SGS Stapler in longitudinal gastric resection. Surgical Endoscopy. https://doi.org/10.1007/s00464-022-09051-x)
Dr. Hoffman is Division Chief of General Surgery at the University of Buffalo (UBMD) Jacobs School of Medicine and Biomedical Sciences. He was the first to use Titan SGS in a surgical setting during the IDE study.