As blogged previously, Enteromedics recently got European approval for their Maestro device for the treatment of obesity.
The system is designed to reduce food intake by blocking vagal signals from the stomach and gut to the brain. The system is implanted laparoscopically and uses high-frequency, low-energy electrical impulses to intermittently block vagal activity (therefore this has also been referred to as VBLOC therapy).
On Friday, Enteromedics now reported rather disappointing preliminary results from their pivotal randomized, double-blind, placebo-controlled EMPOWER study, which failed to meet its primary and secondary efficacy endpoints. In response to this announcement shares of Enteromedics fell by 70%.
This is obviously bad news for the company, but, given past failures with other approaches to neuro- or gastro-stimulation treatments, perhaps also for other companies heavily investing in electrical therapy for weight management.
While the pre-clinical data and preliminary results in select patients, often look promising, confirming these findings in subsequent larger long-term studies apparently proves challenging.
Nevertheless, it may well be that for select patients, neurostimulation could be an effective and safe option - the million-dollar (no pun intended) question however remains: who exactly are these patients?
Once again, it is clear that in obesity treatments, one size will not fit all.
AMS
Edmonton, Alberta
In The News
October 12th, 2009 at 1:52 am
I am not surprised as well. Like you said, there may be a subset of patients in whom it may work. But, how to pre-determine efficacy? We don’t know if such a subset exists at all. Thanks for a most informative posting .. as always.