The new calibration tubes are intended to simplify gastric and bariatric procedures including laparoscopic sleeve gastrectomy, gastric bypass and gastric banding
ReShape has received FDA clearance for the Gastro Intestinal Balloon Indicator calibration tube. (Credit: PublicDomainPictures from Pixabay)
ReShape Lifesciences has received the US Food and Drug Administration (FDA) 510(k) clearance for the Gastro Intestinal Balloon Indicator (GIBI HD) calibration tube.
The new disposable tubes are used in gastric and bariatric surgical procedures.
ReShape, a weight loss and metabolic health solutions company is anticipating the commercial launch of the tubes in September 2022.
Three new sizes – 32, 36, and 40 Fr – are included in the GIBI HD, all intended to make bariatric surgeries like laparoscopic sleeve gastrectomy, gastric bypass, and adjustable gastric banding easier.
The new calibration tube’s large diameter and blunt tip allow for confident placement, quick decompression to provide improved visibility, and guidance to enable straighter staple lines.
According to the firm, the GIBI HD from ReShape Lifesciences is a versatile device as opposed to reusable bougies and disposable stomach tubes.
The GIBI HD is also less stressful for the patient because it is designed to more readily and swiftly access the pylorus due to the stomach’s lessened curvature.
ReShape Lifesciences commercial operations senior vice president Michael Bordainick 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 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.”
“The GIBI HD is a valuable tool for physicians, with a balloon feature that helps bariatric surgeons better visualise the anatomy, making it easier to identify potential defects.”
Bordainick added: “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.”