ReShape Lifesciences' GIBI HD Calibration Tubes Scores FDA Approval For Tummy Tuck Procedures

  • ReShape Lifesciences Inc RSLS 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 company expects U.S. commercial sales to begin in September 2022.
  • 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. 
  • The company says that GIBI HD is a multifunctional device compared to reusable bougies and disposable gastric tubes. The GIBI HD is also less traumatic to the patient, as it is intended to fit the lesser curvature of the stomach more easily and quickly reach the pylorus.
  • Price Action: RSLS shares are up 18.47% at $0.58 during the market session on the last check Wednesday.
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