Bariatric News: vBloc Neurometabolic Therapy
October 26, 2015vBloc Neurometabolic Therapy is the first obesity medical device to be approved by the FDA in 2015. It offers a different approach to weight loss compared to other approved devices or surgical options for adult patients with a Body Mass Index (BMI) of 40 to 45 kg/m2 or a BMI of 35 to 39.9 kg/m2 with a related health condition and who have tried to lose weight in a supervised weight management program within the past five years.
Delivered by a pacemaker-like device called the Maestro® Rechargeable System, vBloc Therapy works by blocking communication on the nerve, the vagus nerve, which serves as the “highway” between the brain and the stomach. By putting up a “roadblock” on the nerve, the communication stops, leading to less hunger and longer periods of fullness.
“vBloc is in an entirely new category as a weight loss treatment. It helps patients lose weight and restore their health without altering or restricting the digestive tract. Many people using vBloc report better control of hunger and earlier fullness, giving them an active tool to make healthier choices and lose weight.”
~ Dr. Aurora D. Pryor
Placement of Maestro
The Maestro System is placed by a qualified surgeon typically during a minimally invasive, outpatient procedure. Sedated patients are implanted with two wires, or “leads,” that are attached to two trunks of the vagus nerve right before the nerve spreads out over the stomach. These leads are attached to the Maestro System, which is implanted just below the surface of the skin, usually on the left side of the body, by the rib cage. The Maestro System then delivers a unique electrical signal, vBloc Therapy, that blocks naturally occurring electrical signals on that nerve.
The therapy is initially programmed to at a certain level and for a certain period of time, usually at the lowest setting and during the patients waking hours. However, the therapy can easily be non-invasively adjusted to meet the patient’s weight loss goals and changing lifestyle needs.
vBloc Therapy is completely reversible and can be both a temporary or permanent weight loss option. If the patient meets their weight loss goals, the device can be explanted or turned off. Conversely, the device can remain implanted in the patient long-term as they continue on their weight loss journey. The device has a rechargeable battery life of over 8 years and can simply be replaced during another outpatient procedure. Patients do need to wirelessly recharge the device every couple of days when implanted in order to receive therapy.
Lifestyle After vBloc Implantation
Following placement of vBloc, patients can continue to maintain a normal, healthy diet without any food type restrictions or forced lifestyle changes, which can make incorporating vBloc Therapy into a patient’s life easier. Patients will have regular follow-up appointments with both a dietician, to help them make health choices on their weight loss journey, as well as a clinician, to ensure the level or therapy or daily programming meets their weight loss goals.
FDA Approval and Positive Results
In January of this year, the Maestro System was approved by the U.S. Food and Drug Administration (FDA) for use in adults with a Body Mass Index (BMI) of 40 to 45 kg/m2 or a BMI of 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years.
vBloc Therapy has demonstrated an ability to lead to significant weight loss. On average, patients in clinical trials, who used the therapy as prescribed, lost 28% of their excess weight by 12 months post implant and saw improvement in obesity related risk-factors, such as LDL cholesterol, triglycerides, blood pressure, heart rate and waist circumference.
These results are complimented by the fact that vBloc Therapy has one of the best safety profiles for a weight loss surgical option and a lower complication rate than other surgical devices. Most adverse events were non-serious and were unrelated to the device, procedure, or therapy. Those that were related were typically mild to moderate in intensity and included pain, heartburn, nausea, difficulty swallowing, belching and abdominal cramping. Because the therapy does not alter or restrict your anatomy, you will not be limited to certain foods and do not have forced major lifestyle changes which may make it easier to incorporate vBloc Therapy into your life.
Contraindications
The Maestro Rechargeable System should not be implanted in patients who have cirrhosis of the liver, portal hypertension, esophageal varices or an uncorrectable, clinically significant hiatal hernia; patients for whom magnetic resonance imaging (MRI) is planned; patients at high risk for surgical complications; patients who have a permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis; or patients for whom shortwave, microwave, or therapeutic ultrasound diathermy is planned.
Warnings/Precautions/Adverse Events
Certain medical therapies or procedures may cause patient injury, nerve damage, burns, heating, or pain; may cause damage to or dislodgement of the implanted device; and may turn therapy off. These include shock wave lithotripsy, radiation, mono polar electrosurgical instruments, positron emission tomography scans, and radiofrequency ablation. Patients who attempt to move the implanted components (“twiddler’s syndrome”) may move, damage or disconnect the system components. The Maestro System components must be kept charged to prevent damage to system components, which may require additional surgery to replace the implanted neuroregulator. The neuroregulator should be fully charged prior to turning it off. Lead impedance testing should only be performed using equipment approved by EnteroMedics to prevent leakage current which could injure the patient. Continued therapy with a fractured lead may cause pain, inflammation or nerve damage.
The Maestro System is MR Unsafe, including for patients in which the Maestro System was explanted and not all components were removed. Maestro System components may interact with other implanted devices, such as cardiac pacemakers, defibrillators, spinal cord and peripheral nerve stimulators, other neurostimulators, and body worn devices such as insulin pumps. Portable outlets or extension cords should not be connected to the AC recharger. Do not immerse external system components in fluid. Keep strong magnets at least 6 inches away from the implanted device. The Maestro Rechargeable System may activate metal detectors or other security systems. Strong magnetic fields and RF emitters, including RFID systems, may interfere with the function of the Maestro System. The neuroregulator and mobile charger should be turned off in the presence of metal detectors, other security systems, strong magnetic fields and RF emitters including RFID systems. The mobile charger should be turned off while aboard aircraft.
The Maestro Rechargeable System should only be implanted by surgeons who have received training in its implantation. Infection at the implant site may occur and could require use of antibiotics, surgery, or device explant. Do not modify any components of the system. Interference from radio frequency transmitters in close proximity to system components may impact function of the Maestro System. Safety and effectiveness of the Maestro Rechargeable System has not been established for use within a hyperbaric chamber, with external defibrillation, during pregnancy, or for use in patients under 18 years of age. The capacity of the rechargeable neuroregulator battery will diminish over time, requiring longer or more frequent charging. Patients with impaired vision may not be able to operate the Maestro System.
The most common related adverse events that were experienced during clinical study of the Maestro Rechargeable System included pain, heartburn, nausea, dysphagia, eructation, wound redness or irritation, and constipation.
Additional Healthcare Provider Information
- vBloc Neurometabolic Therapy is the safest, long-term obesity device option available to patients today
- In the ReCharge Study:
• 93% of patients remained in the trial through 12 months showing that patient acceptance of the therapy is high
• Over 50% of patients lost 20% of their excess weight or more - Several obesity-related conditions were improved:
• Blood pressure and heart rate decreased substantially
• Meaningful improvements in total cholesterol, LDL , triglycerides and HbA1c levels
• On average, patients lost 4-6 inches off their waist
vBloc Therapy is unique in that it does not alter the anatomy or place an object into the stomach, but rather uses an advanced neuroscience-based approach to replicate feelings of fullness and reduced hunger
The video shows the placement of the Maestro System and delivery of vBloc Neurometabolic Therapy. The Maestro System is implanted in a short outpatient procedure. The procedure is completely reversible and does not require altering the patient's anatomy. The Maestro System, which delivers vBloc Neurometabolic Therapy, offer patients a novel, safe, and effective neuroscience-based approach to weight management.
Patient Mike Magnant shares his weight loss success resulting from effective VBLOC® therapy.
https://youtu.be/dIjHC3FAp1w
Photo and Video Credit: EnteroMedics
 | ABOUT THE AUTHOR Dr. Aurora Pryor is Professor of Surgery and Vice Chair for Clinical Affairs, Chief of the Bariatric, Foregut and Advanced GI Surgery Division and Director for the Bariatric and Metabolic Weight Loss Center at Stony Brook School of Medicine in New York. Dr. Pryor serves on the Executive Council of the American Society for Metabolic and Bariatric Surgery (ASMBS). |
