FDA approves innovative implant for obesity treatment
On January 14, the U.S. Food and Drug Administration (FDA) approved a new system for the treatment of obesity in a certain category of adult patients, developed by EnteroMedics. The system is the first device that affects the nerve pathways connecting the stomach and the region of the brain that controls feelings of hunger and satiety.
VBLOC therapy (from Vagal Blocking Therapy) is a method of treating obesity by affecting the vagus nerve (Latin: nervus vagus) with electrodes of a special Maestro Rechargeable System device. These electrodes are implanted into the esophageal-gastric junction using laparoscopic bariatric surgery.
Maestro Rechargeable System is the first device for the treatment of obesity to receive FDA approval since 2007. It is intended for patients aged 18 and over who have failed to lose weight after completing a weight loss program, have a body mass index (BMI) in the range of 35-45 and suffer from at least one of the obesity-associated diseases, for example, type 2 diabetes mellitus.
The system consists of a rechargeable electric pulse generator, wire leads and electrodes surgically implanted into the abdominal cavity. It exerts its effect by emitting periodic electrical impulses into the trunks of the vagus nerve, which are involved in the regulation of gastric emptying and provide the brain with information about the degree of its filling. Despite the fact that experts are aware of the ability of electrical stimulation to block the activity of nerves connecting the brain and stomach, the exact mechanisms of weight loss when using the new device are unclear.
The external control unit allows the patient to recharge the devices, and his attending physician to configure the system to obtain optimal results with minimal risk of unwanted side effects.
The safety and effectiveness of the VBLOC technique were evaluated in a clinical study involving 233 patients with a BMI of at least 35. The degree of weight loss and the frequency of side effects in 157 patients of the experimental group were compared with the corresponding indicators in 76 patients of the control group, implanted with electrical pulse generators were not activated.
12 months after the start of the study, the degree of reduction in excess body weight of patients in the experimental group was 8.5% higher than the results of patients in the control group. About half (52.5%) of patients in the experimental group got rid of at least 20% of excess weight, and 38.3% of patients in this group got rid of at least 25%.
Against the background of therapy, the following serious side effects were recorded: nausea, pain in the area of implantation of the neuroregulator, vomiting, as well as surgical complications. Other side effects included: pain, heartburn, difficulty swallowing, belching, moderate nausea and chest pain.
When conducting a clinical trial, its ultimate goal was not achieved – the difference between the results of reducing excess body weight between the experimental group and the control group was at least 10%. However, the FDA advisory committee considered the data collected over 18 months to confirm a gradual decrease in body weight when using the new system. The Committee agreed that the benefits of using Maestro Rechargeable System in a certain category of patients exceed the risks associated with therapy.
One of the conditions for the approval of the device was the consent of the manufacturer – EnteroMedics, St. Paul, Minnesota - to conduct a 5–year study, which will monitor the condition of at least 100 patients, as well as collect additional data on the safety and effectiveness of the system, including the degree of weight loss, undesirable side effects, surgical revisions and device removals, as well as changes in the course of obesity-associated pathologies.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru according to the FDA: FDA approves first-of-kind device to treat obesity.
19.01.2015