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.”
