European Union (EU) Post-Market Study on Easyband®

EU Post-Market Study on Easyband®

The purpose of this study is to collect additional safety, performance and effectiveness data of the Easyband gastric band medical device in the treatment of morbid obesity in 4 European countries where the device is a CE marked approved product.

Inclusion Criteria:

• Demonstrated failure in losing weight with non-invasive therapies
• BMI ≥ 40 kg/m2, or BMI ≥ 35 kg/m2 and < 40 kg/m2 with one or more significant medical conditions related to obesity

Exclusion Criteria:

• patients with BMI greater than 60 kg/m2
• patients who are not indicated for laparoscopic bariatric surgery
• patients with known allergies to implant materials such as silicone and PEEK
• patients whose abdominal structures have been damaged during preceding surgical procedures
• pregnant women
• patients under the age of 18 years
• patients treated with steroids
• patients addicted to alcohol or drugs, or who are mentally unstable, or who may not comply with the follow-up and dietary restrictions
• patients already implanted with a device sensitive to radio-frequency emissions such as implanted pacemaker, defibrillators, cochlear implants, implantable pumps etc