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August 03, 2010

Mayo Clinic linked anti-obesity device maker firms up

In March of 2005, I launched this blog and news from one medical device firm - EnteroMedics - has been there almost every step of the way since.

I wrote about this St. Paul company and its research and licensing deals with Mayo Clinic twice that first month blogging.

Enteromedicsdevice More than five years later, it is still a name that comes up a couple times a month as its saga yo-yos up and down. Kind of like Brett Farve, but that's another story.

Anyway, EnteroMedics announced Monday that has an OK from the FDA to do a study of its second generation Maestro system on humans. Maestro involves a sort of Pacemaker-like device that tells a person's vagus nerve that the stomach is full.

This is EnteroMedics' second shot at this. In October 2009, results from a study dubbed Empower showed that people with a placebo device lost as much as the actual widget.

Hence the name for this upcoming study - ReCharge.

In May, Mayo Clinic and EnteroMedics re-charged the five year deal they first signed in 2005. They extended it for two more years.

"The collaboration will continue to focus on the research and development of vagal-blocking technology for the treatment of obesity and other gastrointestinal disorders.

EnteroMedics will retain exclusive rights to obesity-related devices developed through this collaboration. Mayo Clinic has licensed technology to EnteroMedics and holds equity in the company"

On Monday, it also announced plans on taking the product to market in Australia, while the studies are done in the U.S.

Here's some from the PR sheet sent out from the firm:

Womanwithmaestro "EnteroMedics Inc., the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced that the Company has received conditional approval for its Investigational Device Exemption application with the U.S. Food and Drug Administration.

The IDE outlines plans for conducting a pivotal trial, the ReCharge Trial, evaluating the safety and efficacy of VBLOC® vagal blocking therapy delivered via the Company's second-generation Maestro® RC System in the treatment of obesity.

The Maestro System is the first obesity treatment to use 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 also announced its plans to commercialize the Maestro RC System in Australia and expects to file an application for approval and listing with the Australian Therapeutic Goods Administration upon receiving CE Mark certification for the Maestro RC System.

EnteroMedics hopes to receive TGA approval during the second half of 2011."

What is next in this weighty saga? I have no idea, but I expect to be blogging on it for at least two more years.

Gotta love job security. Not as good as Favre's, but the best I'm going to do.


i want to invest in the placebo, low cost and just as effective. reminds me of the good old days of the lie detectors, lots of flashing lights and a pedal under the desk., similar results.

I will let the skinny community in on a little secret we larger folks try to keep on the down low... we sometimes eat even when we are not hungry. I know, shocking right?

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