EnteroMedics to submit an IDE application for next-generation Maestro RC System

EnteroMedics Inc.Jan 28 2010

EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, announced today that, following a recent meeting with the U.S. Food and Drug Administration (FDA) to discuss the Company’s EMPOWER™ study results and the regulatory process, the Company intends to submit an Investigational Device Exemption (IDE) application for a clinical trial to support a possible Premarket Approval (PMA) application for the next-generation Maestro® RC System in the treatment of morbid obesity.

“We had a constructive dialogue with the FDA about the regulatory steps necessary to move beyond the EMPOWER trial”

“We had a constructive dialogue with the FDA about the regulatory steps necessary to move beyond the EMPOWER trial,” stated Mark B. Knudson, Ph.D., President and Chief Executive Officer of EnteroMedics. “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.” Dr. Knudson added: “The Company remains fully committed to supporting the patients from the EMPOWER trial of the Maestro RF System.”