EnteroMedics wins CE Mark for obesity therapy

EnteroMedics, a medical device company, has received the CE Mark approval for its Vbloc therapy delivered via the Maestro system for the treatment of obesity.

The Maestro system is the first to treat obesity using neuroblocking technology and represents a less invasive alternative to existing surgical weight loss procedures, which alter digestive system anatomy, lifestyle and food choices and may present significant risks, the company said.

CE Mark approval gives EnteroMedics the ability to market the Maestro system to countries of the European economic area. Vbloc therapy is undergoing clinical testing in the US and Australia in a pivotal trial known as the Empower study. Provided a positive outcome from the study, EnteroMedics will use data from the Empower trial to support a premarket approval application for the Maestro system, which it expects to submit to the FDA in late 2009.

Mark Knudson, president and CEO of EnteroMedics, said: Vbloc therapy is a treatment innovation that offers individuals the promise of significant weight loss without having to accept nutritional, lifestyle and safety compromises. CE Mark approval represents a major milestone for EnteroMedics and is the first step in our global commercialization strategy.