EnteroMedic has reported the clinical data of ReCharge Pivotal Trial in the treatment of obesity, diabetes and hypertension.
The double-blind, multicenter, parallel-group and randomized ReCharge Pivotal Trial is designed to assess the effectiveness and safety of Vbloc vagal blocking therapy in EnteroMedics’ second generation Maestro Rechargeable (RC) System.
The Maestro RC System delivers Vbloc vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the esophagus and the stomach.
The Vbloc vagal blocking therapy aids bariatric surgeons to block the vagus nerves using high-frequency, low-energy electrical impulses.
The therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.
EnteroMedics president and CEO Mark Knudson said they continue to make progress toward commercialization of the Maestro RC System in Europe, having achieved CE mark certification in March, and have similar efforts ongoing in other important markets around the world, including Australia and the US.
"We are working to collect further follow-up data for the DM2 trial and remain on track to achieve full enrollment of our ReCharge pivotal study by year end," Knudson said.