Obesity is a growing global concern with significant medical and economic repercussions. With the increasing prevalence of obesity and its associated comorbidities, there is a rising demand for effective and innovative weight loss solutions. Among these solutions is the VBLOC therapy, delivered by the Maestro System, a device developed by EnteroMedics. This article delves into the details of the VBLOC weight loss device, its manufacturer, how it works, clinical trial results, potential benefits, risks, and other relevant information.
Obesity: A Global Epidemic
Since 1980, the worldwide obesity rate has more than doubled, with approximately 13% of the world’s adult population now being obese. The World Health Organization (WHO) currently estimates that as many as 600 million people worldwide are obese and more than 1.9 billion adults are overweight. In the United States alone, millions of adults are obese, having a BMI of 30 or higher. It is projected that a significant portion of the population will be obese in the coming years.
Obesity is associated with numerous significant weight-related comorbidities, including Type 2 diabetes, high blood pressure, sleep apnea, certain cancers, high cholesterol, coronary artery disease, osteoarthritis, and stroke. A substantial percentage of adults with a BMI above 30 have comorbidity, and a significant portion have multiple comorbidities. A considerable number of cancer deaths each year are linked to excess body weight, poor nutrition, and/or physical inactivity. Obesity can be attributed to a significant percentage of healthcare costs.
EnteroMedics: Innovators in Obesity Treatment
EnteroMedics is a medical device company that specializes in developing and commercializing innovative technologies to treat obesity and metabolic diseases. The company's flagship device, the Maestro System, delivers VBLOC therapy, a novel approach to weight loss.
VBLOC Therapy: How it Works
The Maestro Rechargeable System is "the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness," according to the Food and Drug Administration statement. The device works by sending intermittent electrical pulses to the abdominal vagus nerve.
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The vagus nerve is the main pathway for communication between the stomach and the brain. VBLOC helps regulate this communication by intermittently blocking the hunger signals to the brain. This is what helps patients feel less hungry between meals and feel full and satisfied on smaller amounts of food at mealtimes.
The system includes a rechargeable electrical pulse generator implanted into the lateral chest wall, connected to two electrical leads placed around the abdominal vagus nerve via a laparoscopic procedure. The manufacturer, EnteroMedics, refers to the treatment as "VBLOC therapy," delivered by the Maestro System.
FDA Approval and Clinical Trial Data
Food and Drug Administration (FDA) approval for VBLOC Therapy, delivered via the Maestro System, is for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 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 and failed within the past five years.
FDA approval was based on the results of the ReCharge study of 233 patients with a body mass index of at least 35 kg/m2; the device was activated in 157 patients, and the remaining patients had the device implanted but it was not activated and they served as controls. After 12 months, those with the activated device lost 8.5% more excess weight than did the controls. Among those who had the device activated, almost 53% lost at least 20% of their excess weight and 38% lost at least 35% of their excess weight, according to the FDA. The patients in the research studies had an average of 28% excess weight loss in one year.
The study did not meet the primary effectiveness endpoint, which was that those on active treatment would lose at least 10% more excess weight than would the controls. However, the majority of an FDA advisory panel that reviewed the data at a meeting supported approval, agreeing that the benefits outweighed the risks for the proposed indication. Panelists cited the fact that the study safety endpoint was met and that the device was effective in helping some people lose weight.
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As a condition for approval, EnteroMedics is required to conduct a 5-year postmarketing study that will collect safety and effectiveness data in at least 100 patients, including weight loss, adverse events, surgical revisions and explants and changes in obesity-related comorbidities, according to the FDA.
Benefits of VBLOC Therapy
EnteroMedics designed ReShape vBloc to address a significant market opportunity that exists for a patient-friendly, safe, effective, less-invasive and durable therapy that is intended to address the underlying causes of hunger and obesity.
- Preserves Normal Anatomy: The ReShape vBloc is designed to deliver therapy that blocks the neural signals that influence a patient’s hunger and sense of fullness without altering digestive system anatomy. One of the reasons that VBLOC is so popular is that there is no cutting, stapling or re-routing of internal organs.
- Allows Continued Ingestion and Digestion of Foods Found in a Typical, Healthy Diet.
- May be Implanted on an Outpatient Basis and Adjusted Non-Invasively: The ReShape vBloc is designed to be laparoscopically implanted within a procedure, allowing patients to leave the hospital or clinic on the same day. The implantable system is designed to be turned off and left in place for patients who reach their target weight. When desired, the follow-up physician can simply and non-invasively turn the therapy back on. The device can be turned off, or completely removed if the patient desires. The device is controlled by wireless technology in Dr. Ellner’s office.
- Offers Favorable Safety Profile: In clinical trials, including the ReCharge trial, there has been no mortality related to the device or any unanticipated adverse device effects.
- Targets Multiple Factors that Contribute to Hunger and Obesity.
- Minimizes Changes to Normal Anatomy.
- Minimally Invasive Procedure. Removable/Reversible.
Components of the Maestro System
- Neuroregulator: The neuroregulator, a pacemaker-like device, is an implanted device that controls the delivery of vBloc Therapy to the vagus nerve.
- Lead System: Proprietary leads are powered by the neuroregulator and deliver electrical pulses to the vagus nerve via the electrodes.
- Mobile Charger: The mobile charger is an electronic device worn by the patient externally while recharging the device.
- Transmit Coil.
- Clinician Programmer: The clinician programmer connects to the mobile charger to enable clinicians to customize therapy settings as necessary and retrieve reports stored in system components. The reports include patient use and system performance information used to manage therapy.
Implantation Procedure and Usage
ReShape vBloc is implanted by a laparoscopically trained surgeon using a procedure that is typically performed. During the procedure, the surgeon laparoscopically implants the electrodes in contact with the vagal nerve trunks and then connects the lead wires to the neuroregulator, which is subcutaneously implanted. The implantation procedure and usage of the ReShape vBloc carry some risks, such as the risks generally associated with laparoscopic procedures as well as the possibility of device malfunction.
The physician activates ReShape vBloc after implantation. VBLOC Therapy is then delivered intermittently through the neuroregulator each day as scheduled (recommended during the patient’s waking hours when food is consumed) through the neuroregulator. The physician is able to download reports to monitor patient use and system performance information. This information is particularly useful to physicians to ensure that patients are properly using the system.
Risks and Side Effects
Serious adverse events in the ReCharge study were nausea, pain at the neuroregulator site, vomiting, and surgical complications; other adverse events were heartburn, problems swallowing, belching, mild nausea, and chest pain, the FDA noted. Although usage of ReShape vBloc generally proceeds without complications, as part of the therapy or intentional weight loss, patients in clinical trials have observed side-effects such as transient pain at the implant site, heartburn, bloating, dysphagia, eructation, cramps, diarrhea, nausea, constipation, and excessive feelings of fullness, especially after meals.
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Contraindications
VBLOC Therapy is contraindicated for use in patients with cirrhosis of the liver, portal hypertension, esophageal varices or an uncorrectable, clinically significant hiatal hernia; patients for whom magnetic resonance imaging (MRI) or diathermy use is planned; patients at high risk for surgical complications; and patients who have a permanently implanted, electrical-powered medical device or gastrointestinal device or prosthesis.
The vBloc Now Program
EnteroMedics launched the vBloc Now program. The program provides qualified patients access to vBloc® Therapy at a reduced cost in partnership with select bariatric and weight loss centers across the United States. The vBloc Now program provides qualified patients battling obesity the opportunity to receive vBloc Therapy including the device, procedure, and vBloc Achieve follow up program at an affordable price in exchange for sharing detailed health data with EnteroMedics.
Alternatives to VBLOC Therapy
The market for obesity treatments is competitive, subject to technological change and significantly affected by new product development. Primary competition in the obesity treatment market is currently from bariatric surgical procedures and from endoscopic procedures.
Surgical Procedures
In more severe cases of obesity, patients may pursue more aggressive surgical treatment options such as gastric banding, sleeve gastrectomy and gastric bypass. These procedures promote weight loss by surgically restricting the stomach’s capacity and outlet size.
Endoscopic Procedures
An overarching strategy for our company is to develop and commercialize a product portfolio that is differentiated from our competition by offering transformative technologies to bariatric surgeons and gastroenterologists that consists of a selection of patient friendly, non-anatomy-changing alternatives to traditional bariatric surgery.
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