EnteroMedics has reported that it intends to submit an Investigational Device Exemption (IDE) application for a clinical trial to support a possible Premarket Approval (PMA) application for the Maestro RC System in the treatment of morbid obesity.
The company has reported that, following a meeting with the FDA to discuss the company’s Empower study results and the regulatory process, it has intended to submit the IDE approval.
Mark Knudson, president and chief executive officer of EnteroMedics, said: “We had a constructive dialogue with the FDA about the regulatory steps necessary to move beyond the Empower trial. The Agency and the company discussed regulatory direction for the Maestro System and the product approval process in support of our efforts to bring VBLOC therapy to market.
“As an outcome of this meeting, we will begin the next step in that regulatory process by preparing an IDE application for submission in the first quarter of 2010. The company remains fully committed to supporting the patients from the Empower trial of the Maestro RF System.”
The company’s neuroblocking technology, vagal blocking therapy (VBLOC), is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses.
These electrical impulses are delivered by a neuroregulator which is powered either by an external controller (Maestro RF System) or an integrated rechargable battery (Maestro RC System). The company is currently conducting a feasibility study examining VBLOC therapy’s effects on blood glucose levels in diabetic patients outside of the US.