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

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