PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

The purpose of this clinical study is to verify the long term effecacy and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with obesity.

Inclusion Criteria:

1. Subject is aged 18 to 65.
2. Body Mass Index [BMI] >40 kg/m2.

Exclusion Criteria:

1. Medical contraindications for general anesthesia, craniotomy, or DBS surgery
2. Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
3. Participate in other clinical trial;
4. Has a life expectancy of < 1 year.
5. The investigator and/or enrollment review committee, would preclude participation in the study.