AS announced by the St. Paul, Minnesota Company, EnteroMedics has received the European CE Mark Certification for the Maestro RC System. This CE Mark has been awarded by the European Commission which is acknowledged by Australia and many other nations of World.
Maestro RC is known to be an anti-obesity device with the use of which hunger of an individual can be easily suppressed. Yes, using electricity the nerve signals between the brain and stomach can be easily blocked. As a result of the initial “Empower” studies, it has been revealed that there was a similar weight loss among those implanted with a dummy device of this and those using the Maestro device.
However, a new clinical trial named “ReCharge” has been approved by the U. S. Food and Drug Administration. Also, it has been further announced by EnteroMedics that the new trials were on track. Approval from FDA for Maestro device is expected to come in 2012.
Initially, EnteroMedics as a part of its annual report targeted approval from local governments, regulatory bodies, or agencies in other countries as well. And according to their report, the initial steps towards regulatory approval and commercialization of neuroblocking product in Australia have been already done. The company is also investigating commercialization opportunities in additional international markets.












