Vagus Nerve Blocking Obesity Treatment on the Road to FDA Approval

EnteroMedics Inc., has developed neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders.  In a move that is a precursor to full market approval, the U.S. FDA has accepted for filing the Company’s Premarket Approval (PMA) application for its Maestro® Rechargeable System’s VBLOC® vagal blocking therapy as a treatment for obesity.

Background

EnteroMedics’ VBLOC vagal blocking therapy works on the principle that intermittently blocking the vagus nerve can influence a person’s perception of hunger and fullness. As such it could be a less invasive and lower risk alternative to surgical weight loss procedures. Furthermore it avoids modification of the patient’s digestive system anatomy, lifestyle and food choice changes.

The Maestro RC System delivers VBLOC vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the esophagus and the stomach. The Maestro RC System is powered by an internal, rechargeable battery. The battery is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week.

As previously announced, the FDA indicated in a pre-PMA meeting that, subject to a detailed review of the submitted data, the Company can anticipate presenting the PMA before a future FDA Advisory Committee panel. The accepted PMA application includes data from the Company’s ReCharge Pivotal Trial, a prospective, double-blind, sham-controlled clinical trial involving 239 randomized patients (233 implanted) at ten sites in the United States and Australia.

Company comments

“The Maestro System holds the potential to fill a significant gap in the obesity treatment landscape, offering a unique, patient-friendly approach to addressing the long term challenges associated with obesity,” said Mark B. Knudson, Ph.D., EnteroMedics’ President and Chief Executive Officer. “FDA acceptance for filing of our PMA application is an important step toward this goal. We look forward to working closely with the FDA during the review process, continuing through an advisory committee panel and approval decision, as we prepare for U.S. commercialization of the Maestro System.”

Regulatory status

The Maestro RC System has received CE Mark and has been listed on the Australian Register of Therapeutic Goods.

Source: EnteroMedics, Inc., Marketwired