EnteroMedics has submitted premarket approval (PMA) application to the US Food and Drug Administration (FDA) for Maestro Rechargeable System's VBLOC, a vagal blocking therapy to treat obesity.
Maestro RC system delivers vagal blocking therapy through two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve, just above the junction between the oesophagus and the stomach.
The submitted PMA application includes data from the ReCharge Pivotal Trial, a prospective, double-blind, sham-controlled clinical trial involving 239 randomized patients, of which 233 patients were implanted with the device, at ten sites in the US and Australia.
EnteroMedics president and CEO Dr Mark B Knudson said the Maestro System holds the potential to fill a significant gap in the obesity treatment arena, offering a unique, patient-friendly approach to addressing the long term challenges associated with obesity.
"FDA acceptance for filing of our PMA application is an important step toward this goal.
"We look forward to working closely with the FDA during the review process, continuing through an advisory committee panel and approval decision, as we prepare for U.S. commercialization of the Maestro System," Dr Knudson added.
The system is powered by an internal, rechargeable battery that can be recharged via an external mobile charger and transmit coil that the patient uses for a short time each week.
This system has received CE Mark and has been listed on the Australian Register of Therapeutic Goods.