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Home Treated Conditions Diabetes EnteroMedics Submits PMA of the Maestro VBLOC System for Treatment of Obesity
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EnteroMedics Submits PMA of the Maestro VBLOC System for Treatment of Obesity

EnteroMedics  reported that it has submitted its pre-market approval application for FDA review of its Maestro Rechargeable System’s VBLOC vagal blocking therapy as a treatment for obesity

This is an important step for an implantable device company that faced very tough times in 2009 after its US clinical trial failed to meet a critical effectiveness goal. EnteroMedics conducted a pivotal trial, and believes that the data are positive, leading it to submit the PMA application.

According to the press release, EnteroMedics president & CEO Mark Knudson said that “the Maestro System is a unique, neuroscience-based approach to the treatment of this epidemic disease, one which offers the potential to fill a significant gap in the obesity treatment spectrum. In the hundreds of patients treated to date, in addition to showing clinically meaningful weight loss, VBLOC Therapy has demonstrated an excellent benefit-to-risk profile; a criterion identified by the Agency as central to the review and approvability of new obesity treatment devices.”

 

 
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