Active implantable medical devices by EnteroMedics
EnteroMedics reported new clinical trial data for its Maestro system, which is designed to treat obesity through vagus nerve stimulation. The company said that its Maestro RC system lost 25% of their excess weight, or 10% of their total body weight, after 18 months. Patients who received a sham implant lost 12% of excess weight, or 4% of their total weight. The company is running a five-year study of the system. The system is approved in Europe and Australia, but not the U.S.
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.”
Today EnteroMedics recorded revenue for the first time since it was incorporated nearly eight years ago. The company reported revenue of about $123,000 in the first quarter of the year from the sale of its Maestro RC implantable vagus nerve stimulation system for treating obesity. Revenue was generated through sales by its distribution partner in Australia.
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 is currently conducting a pivotal trial that is expected to end in Q4 2012. EnteroMedics expects to file a premarket approval application with the FDA in the first half of 2013 if the data from the trial is positive.
Leptos Biomedical was founded in Fridley, MN in 2002 by Dr. John D. Dobak. Leptos intended to develop an implantable device to stimulate the greater splanchnic nerve, that was hoped would result in reduced food intake and increased energy expenditure.
In February 2010 Leptos announced its closure. Reasons were not provided, but it has been suggested that the decision was prompted by the 2009 announcement by competitor EnteroMedics’ that it had failed to meet the primary goals of its pivotal study. EnteroMedics’ Maestro device didn’t perform any better than a sham device. EnteroMedics is now conducting a new study with the device.
Click here for Leptos Biomedical’s patents.
EnteroMedics Inc. was founded in St. Paul, MN in 2002 to develop a platform for vagus-nerve stimulation, primarily for obesity management. In March 2011 EnteroMedics received the CE Mark for its second-generation system – the Maestro RC.
The EnteroMedics Maestro RC device delivers VBLOC® vagal blocking therapy to through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. VBLOC Therapy is intended to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness. Continue reading