BAROnova’s TransPyloric Shuttle Device Receives FDA’s Approval for the Treatment of Obesity in Adults

BAROnova’s TransPyloric Shuttle Device Receives FDA’s Approval for the Treatment of Obesity in Adults

Shots:

  • The approval is based on ENDObesity II study results assessing TransPyloric Shuttle (TPS) vs sham in 302 patients suffering from obesity with a BMI of 30-40 kg/m2 in 9 centers across the US
  • The ENDObesity II study results: @12mos. loss 3.4x weight (9.5% vs 2.8%); weight loss>10%of body wt. (40% vs 14%); 67% loss >5% of body wt.; improvement in BP, cardiometabolic risk factors & QoL
  • The TransPyloric Shuttle is a device made up of solid silicone involves delayed gastric emptying which results in weight reduction and is designed to be delivered & retrieved endoscopically to reside in the stomach for 1 year

Click here to read full press release/ article | Ref: PRNewswire | Image: General Surgery News