EnteroMedics wins European approval for Maestro RC weight loss device

March 30, 2011 by MedCity News

EnteroMedics Inc. lands CE Mark approval for its Maestro RC weight loss system and begins taking steps for approval in Australia.


EnteroMedics Inc. (NSDQ:ETRM) received CE Mark approval for the Maestro RC system.

The St. Paul, Minn.-based company previously announced its intention to target approval in other countries in its annual report, and stated that it had completed initial steps to both work toward regulatory approval and commercialize the neuroblocking product in Australia.

The company is also exploring commercialization opportunities in additional international markets, according to the annual report.

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CE Mark approval is a prerequisite for Australia’s Therapeutic Goods Administration (TGA) approval. Once TGA approval is obtained, EnteroMedic expects commercial sales of the Maestro system to begin in the second half of 2011. The company has already signed a distribution agreement with Australian medical technology distributor Device Technologies Australia.

Maestro RC is an anti-obesity device that uses electricity to suppress hunger by blocking the nerve signals between the brain and stomach. Initial results from the “Empower” studies showed that those implanted with a dummy device lost just as much weight as those using the Maestro device.

However, the FDA approved a new clinical trial called “ReCharge.” The company hopes to gain FDA approval for the Maestro device in 2012.

EnteroMedics reported losses of $17.3 million for the full year 2010, and losses of $4 million for the fourth quarter ending Dec. 31, 2010. Much of this was due to the expenses associated with clinical trials, and with the continued development of the vagal-blocking therapy delivered through the Maestro system. EnteroMedics completed a $29.8 million public offering of common stock and warrants in December.