|Maestro VBLOC antiobesity device.--Courtesy of EnteroMedics|
EnteroMedics ($ETRM) filed with the FDA for premarket approval of a neuroblocking device designed to treat obesity, despite mixed results in a pivotal trial.
The Maestro Rechargeable System uses two small electrodes to deliver VBLOC vagal blocking therapy. The electrodes are laparoscopically implanted between the esophagus and the stomach and are powered by an internal, rechargeable battery via an external mobile charger, according to the company. The electrical pulses are meant to curb hunger.
The device has already procured a CE mark and a spot on the Australian Register of Therapeutic Goods, but EnteroMedics is taking a risk entering the FDA process with the less-than-stellar results it has in its pocket. In an early 2013 trial, VBLOC didn't meet its defined primary efficacy measures, but the company remains optimistic about its odds. The device did show 24.4% statistically significant excess weight loss in the trial, and more than half of the patients achieved at least 20% weight loss.
"In the hundreds of patients treated to date, in addition to showing clinically meaningful weight loss, VBLOC Therapy has demonstrated an excellent benefit-to-risk profile, a criterion identified by the (FDA) as central to the review and approvability of new obesity treatment devices," EnteroMedics CEO Mark Knudson said in a statement. "We look forward to maintaining a very open and productive dialog with the FDA throughout the review process."
- here's the release