EnteroMedics, a development stage medical device company focused on the design and development of devices that use neuroblocking technology to treat obesity and other gastrointestinal disorders, has submitted an investigational device exemption (IDE) application with the FDA for its Maestro RC System in the treatment of morbid obesity using VBLOC vagal blocking therapy.
The submission is the first step in the iterative IDE review process in support of a possible premarket approval (PMA) application.
EnteroMedics’ proprietary neuroblocking technology VBLOC vagal blocking therapy is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. The electrical impulses are delivered by a neuroregulator which is powered either by an external controller (Maestro RF System) or an integrated rechargeable battery (EnteroMedics’ next-generation Maestro RC System).
EnteroMedics is currently conducting a feasibility study examining VBLOC Therapy’s effects on blood glucose levels in diabetic patients outside of the US.
Mark Knudson, president and CEO of EnteroMedics, said: “This IDE submission marks an important next step in advancing our Maestro RC System toward a pivotal study in obesity. We look forward to working through the IDE review process with the FDA. We expect to be in a position to provide an update on our strategy after this process has reached a conclusion.”