ReShape Lifesciences has received FDA 510(k) clearance for the disposable, Gastro Intestinal Balloon Indicator (GIBI HD) calibration tube for use in gastric and bariatric surgical procedures. The GIBI HD includes three new sizes - 32, 36 and 40 Fr - all designed to simplify bariatric procedures such as laparoscopic sleeve gastrectomy, gastric bypass and adjustable gastric banding.
According to the company, the large diameter and blunt tip design of the new calibration tube allows for confident placement and rapid decompression to ensure greater visibility and provide guidance to allow for straighter staple lines. Additionally, compared to reusable bougies and disposable gastric tubes, ReShape Lifesciences’ GIBI HD is a multifunctional device and is also less traumatic to the patient as it is intended to fit to the lesser curvature of the stomach more easily and quickly reach the pylorus.
“FDA clearance of our GIBI HD calibration tube, which supports bariatric procedures across the spectrum, marks an important addition to our suite of physician led weight loss solutions and we look forward to formally introducing this important new product at the International Federation for the Surgery of Obesity and Metabolic Disorders – IFSO 2022 World Congress in Miami, later this month,” stated Michael Bordainick, Senior Vice President, Commercial Operations at ReShape Lifesciences. “The GIBI HD™ is a valuable tool for physicians, with a balloon feature that helps bariatric surgeons better visualize the anatomy, making it easier to identify potential defects. As we have communicated to the market, we continue to innovate our pipeline of physician prescribed, insurance reimbursed weight loss solutions including the Lap-Band Program, supportive reshapecare Virtual Health Coaching Platform and the ReShape Optimize line of supplements by ProCare Health, available on ReShape Marketplace. It is truly an exciting time for ReShape as we solidify our position as the premier physician-led weight loss and metabolic health-solutions company.”
The company expects US commercial sales of its GIBI HD calibration tube to begin in September 2022.