EnteroMedics, a healthcare products manufacturer based in St. Paul, Minnesota, announced the results of a clinical trial for its VBLOC antiobesity system. According to a press release by the company, the clinical trial showed mixed efficacy for the device.
In its press the release, the company stated the VBLOC antiobesity device did not meet its efficacy goals in the trial. The ReCharge sham-controlled double-blind trial comprised 239 different patients in Australia and the United States. Out of these 239 participants, 233 received the implant.
While the weight loss device was not able to meet its predefined goal, it was able to meet its primary safety endpoint. In addition, the device was able to help more than 50 percent of patients lose 20 percent of their weight. In summary, the company stated that the VBLOC device was able to help patients achieve a 24.4 percent statistically significant overall weight loss.
Mark Knudson is the CEO of EnteroMedics. During a conference call yesterday, he said, "Right now it is our belief that this was a very positive outcome in this trial." He continued, "We have a very strong dataset to go to the FDA with. We do not anticipate that we will need to do any more work to be able to show very high benefit, and low risk, and move very confidently forward with our application to the agency."