Fda Approval Of The Vbloc Therapy System Essay

Fda Approval Of The Vbloc Therapy System Essay

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FDA Approval
Approval of the VBLOC therapy system was very controversial. The FDA advisory panel voted yes on the device’s safety and benefits outweighing the risk, but no on the efficacy of the device. This is due to the fact that in a sham-controlled study, the Maestro VBLOC therapy system didn’t show a significant increase in weight loss compared to the sham. Although it still helped individuals lose more weight, it was not enough to meet the FDA’s super-superiority standard[12,15].
However, the Obesity Action Coalition aided EnteroMedics by bringing forth four subjects from the study. These patients testified to the advantages of the device and the value that it had for obese individuals. Along with comments from physicians, statisticians, and other organizations, the FDA finally agreed to change their decision and approve the Maestro VBLOC therapy system.
In addition to this controversy, the FDA also had concerns about the studies conducted on the Maestro VBLOC therapy system. Most notably was that the subjects in the study was largely Caucasian and female and that the study was only conducted for an 18 month period[12]. Thus, the FDA set more guidelines for future studies of the Maestro VBLOC therapy system, setting a minimum number of male and ethnic minority subjects, and a post-approval 5 year study to test the long term effects of the device. With these restrictions, if anything goes wrong in future studies of the VBLOC therapy system, it runs the risk of being taken off the market. For now, however, the Maestro VBLOC therapy system will be placed on the market because of the urgent need for morbidly obese individuals to find better treatment.

Efficacy
The Maestro VBLOC therapy system targets individuals who are ...


... middle of paper ...


...ly concern would be the price of the system, which is currently the same cost as gastric bypass surgery; for the same amount of money, it would make more sense for individuals to choose the option that helps them lose more weight. In addition, the device could be improved upon by stopping the electric pulse at normal eating times of the day. A user interface could be created to allow patients to enter how much food calories they have consumed in a day, information that the Maestro VBLOC therapy system can use to control when to block hunger signals. In the end, the goal of the product is to help individuals lose weight, not starve them. However, the Maestro VBLOC therapy system has already demonstrated the ability to help morbidly obese individuals lose a significant portion of their excess body weight, and should serve as an effective solution to help combat obesity.

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