Boston, MA 06/20/2014 (wallstreetpr) – EnteroMedics Inc (NASDAQ:ETRM) is developing a device implant to control obesity in adults with refractory conditions. The device helps the obese by controlling appetite and digestion. The development of the device received a major boost this week when an advisory panel of the Food and Drug Administration (FDA) voted favorably on its safety and potential.
In the U.S., obesity is almost hitting epidemic proportions because more than one third of the country’s population are said to be obese. According to a lobby group called Trust for America’s Health, obesity costs the U.S. healthcare up to $210 billion annually, based on 2012 findings.
The widespread obese conditions in the U.S. has even become a serious concern for the U.S. policymakers and regulators, who have to encourage innovative ways to deal with the situation while also ensuring that patients are only exposed to the best obesity treatment or remedy.
EnteroMedics Inc (NASDAQ:ETRM) is developing a device dubbed Maestro Rechargeable System (MRS), which helps to control appetite and stomach activities.
FDA Review Of ETRM Implant
In a vote, the FDA panel voted eight to one to recommend the device as safe. As to whether the benefits of the device outweigh its risks, the panel voted six to two in its favor, in a vote that saw one member abstain. On the efficacy side, MRS suffered a blow as only four out of five members supported it on that front. However, overall, the vote was deemed positive.
The FDA usually follows the recommendations of its independent committees, however, and it is not compelled to do so. If the device wins approval of the regulator, it will become the first obesity targeted implant in more than a decade in the U.S.
Final Decision
EnteroMedics Inc (NASDAQ:ETRM) expects the final decision on the Premarket Approval (PMA) of the market to come later this year. The device, which works through a technology known as neuro blocking, would be an important addition to the obesity treatment market, especially considering that obesity begets medical problems such as cancer, hypertension and diabetes.