The FDA has approved a new obesity treatment device that sends a high-frequency (5,000 hertz) electric pulse into a key nerve that helps the brain communicate with other major organs such as the heart, lungs, and digestive system.
The Maestro Rechargeable System is the first medical device the FDA has approved for treating obesity since the gastric band Ethicon in 2007, and consists of wire leads and electrodes directly implanted above the stomach as well as rechargeable pulse generator. For the time being, it is approved only for use in severely obese adults (BMI, or Body Mass Index 35-45) who have not been able to achieve results with a weight loss program and who suffer from other conditions related to obesity, such as Type 2 diabetes.
Even though a clinical study of the device did not meet its goal, the FDA concluded that the benefits outweighed the dangers. “Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown,” the FDA wrote in its press release.
Side effects reported by the 233 participants in a clinical trial have included pain in the area, nausea, heartburn, and chest pain.
The manufacturers have not set a price yet, but estimates range between $15,000 and $40,000. By comparison, the Wall Street Journal reported, a gastric band runs at around $20,000, while gastric bypass surgeries start at around $30,000.
Analysts say that while many details remain to be sorted out, the device addresses an important niche and is likely to see considerable demand. “There are a lot of patients in this gap between drugs and exercise and changes in diet, and the more invasive bariatric surgical options like Lap-Band,” Chris Lewis, an analyst at Roth Capital Partners, told Bloomberg.
“This fills that gap.”