The U.S. Food and Drug Administration (FDA) has announced 510(k) clearance to ReShape Lifesciences’ RSLS Gastro Intestinal Balloon Indicator (GIBI HD) calibration tube for use in gastric and bariatric surgical procedures.
The GIBI HD is designed to simplify bariatric procedures such as laparoscopic sleeve gastrectomy, gastric bypass and adjustable gastric banding.
Michael Bordainick, Senior Vice President, Commercial Operations, said, "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. 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.”
The company is planning to introduce GIBI HD, the new product at the International Federation for the Surgery of Obesity and Metabolic Disorders – IFSO 2022 World Congress in Miami, later this month.
The commercial sales of the product in the United States is expected to begin in September 2022.
Price Action : ReShape shares are trading around 27 percent higher at $0.62 on Wednesday at the time of publication.
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