Surgically Implanted Device Received FDA Node to Treat Obesity

The US Food and Drug Administration has accepted a new weight loss treatment device. The device focuses on the nerve pathway in between the brain and the stomach that manages feelings of hunger and fullness.

The Maestro Rechargeable System, the initial FDA-accepted obesity device since 2007, has been allowed to treat sufferers aged 18 and above who have struggled to shift the pounds with a weight loss program.

To be qualified for therapy inclusion, sufferers should have a body mass index (BMI) of 35-45 with at minimum one other obesity-associated problem, like as type 2 diabetes.

With respect to the Centers for Disease Control and Prevention (CDC), about 33 % of all US adults are overweight. These obese people are at a greater risk of enduring from heart disease, heart stroke, type 2 diabetes and specific cancers.

Deputy Director for science and chief scientist of the FDA’s Center for Devices and Radiological Health Dr. William Maisel, says that:
“Obesity and its associated medical problems are main public health issues; medical devices can assist doctors and sufferers to develop comprehensive obesity therapy plans.”

The Maestro Rechargeable System, produced by EnteroMedics of St. Paul, MN, consists of a rechargeable electrical pulse generator, wire leads and electrodes, which are inserted into the abdomen. The equipment perform by delivering intermittent electrical pulses to the stomach vagus nerve, which is engaged in controlling stomach emptying and signaling to the brain that the stomach seems either empty or full.
It is identified that electrical stimulation prevents nerve activity from the brain to the stomach. On the other hand, the particular mechanisms for weight loss caused by use of the device are unidentified.

Active device group lost 8.5% additional extra weight than control group
A clinical study composed of 233 sufferers with a BMI of 35 or more was performed to assess the safety and effectiveness of the Maestro Rechargeable System. The body weight loss and adverse events of 157 sufferers who obtained the active device were compared with 76 sufferers in the control group who obtained a device that was inactive.

The trial identified that after 12 months:
 The trial group lost 8.5% more extra weight than the control group
 52.5% of the sufferers in the experimental group lost at least 20% of their extra weight
 38.3% of sufferers in the experimental group lost a minimum of 25% of their excess weight.

The primary endpoint of the research was for the group with the active device to lose at the least 10% more extra weight than those in the control group – this was not fulfilled.

On the other hand, FDA Advisory Panel (the Gastroenterology and Urology Devices committee) identified the 18-month data supportive of sustained weight loss and agreed that the advantages of the device outweighed the dangers for use.

While examining the advantages and threats of the Maestro Rechargeable System, the FDA regarded the suggestions of the Advisory Panel and in addition analyzed an FDA-sponsored survey related to patient choices of obesity devices.

The survey suggested that the group of sufferers were ready to take the risks related with the surgically implanted device for the amount of weight loss it was predicted to offer.

As part of the FDA-approval rules, the producer must perform a 5-year post-approval research to observe a minimum of 100 sufferers. Data should be gathered on safety and effectiveness such as weight loss, adverse events, surgical changes and explants and improvements in obesity-related problems.

Serious and other adverse events stated in the clinical research include:
 Nausea
 Vomiting
 Heartburn
 Belching
 Chest pain
 Pain at the neuroregulator site
 Surgical complications
 Problems swallowing

The FDA helps to protect public health by ensuring the safety, effectiveness and security of medicines, vaccines, biological products and medical devices for human use.