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Overview

 
 

About vBloc® Therapy

 

vBloc® Maestro® System

 
 

Obesity

 
 

Clinical Experience

 
 

     Obesity

 
 

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Important Safety Information for Patients >
 

 

There is a significant need for an innovative treatment to address the growing worldwide obesity epidemic, which contributes significantly to growing health care costs. EnteroMedics® has developed a unique, proprietary neuroblocking technology, VBLOC® vagal blocking therapy, to address this need.

The Vagus Nerve
Science Behind vBloc® Therapy
vBloc® Therapy
Benefits of vBloc® Therapy and the Maestro Rechargeable System
Risks of vBloc® Therapy and the Maestro Rechargeable System
 


The Vagus Nerve

The vagus nerve regulates many activities in the human body, affecting digestion and activities of the stomach, intestine and pancreas, providing direct two-way communication between the brain and body. Vagus nerve function has been shown to play a role in enabling multiple gastrointestinal and metabolic mechanisms, including:

  • Expansion of the stomach as food enters

  • Stomach contractions that break food into smaller particles

  • Release of gastric acid to continue food processing

  • Emptying of the stomach contents into the small intestine

  • Secretion of digestive pancreatic enzymes that enable absorption of calories

  • Sensations of hunger, satisfaction and fullness

Science Behind vBloc® Therapy

Early research of the vagus nerve and its effect on the digestive system focused on the effects of surgical vagotomy, or severing of the vagus nerve near the stomach, which was used historically as a treatment for peptic ulcers. These studies demonstrated that patients often experienced weight loss and reduced appetite following vagotomy. However, these effects were not sustainable because the body compensated for the anatomical disruption.

Learning from these studies, EnteroMedics designed vBloc® Therapy to intermittently block vagus nerve signaling using an implantable, pacemaker-like device. Intermittent blocking helps minimize the negative side effects that may be experienced with vagotomy and mitigate the accommodation response to a permanent and complete block.

vBloc® Therapy

vBloc® Therapy targets the multiple physiologic effects of the vagus nerves, affecting perceptions of hunger and fullness.

vBloc® Therapy intermittently blocks intra-abdominal vagus nerve signaling – or transmission of messages involving food intake and processing -- between the brain and stomach using a pacemaker-like implant called the Maestro® Rechargeable System.

vBloc® Therapy targets vagal nerve function by blocking the signals carried along this nerve, which may reduce appetite and create weight loss by limiting the expansion of the stomach and by reducing the frequency and intensity of stomach contractions. vBloc® Therapy may also reduce the absorption of calories by decreasing the secretion of digestive enzymes. Intermittent therapy allows the vagus nerve to return to function between active therapeutic episodes, thereby limiting the body’s natural tendency to circumvent the therapy.

vBloc® Therapy involves a minimally invasive laparoscopic procedure that preserves normal digestive system anatomy. The Maestro Rechargeable System, which delivers vBloc® Therapy, is implanted and non-invasively programmed by a physician to best meet the individual patient's needs. This device can be adjusted, deactivated, reactivated, or completely removed if desired. Patients maintain control of their lifestyle while being supported in their effort to lose weight safely - and privately if they wish. With no food restrictions or associated nutritional deficiencies, vBloc® Therapy equips patients to address the significant behavioral, lifestyle and social challenges associated with this chronic disease, making it an encouraging and innovative development in the treatment of obesity.

Benefits of vBloc® Therapy and the Maestro Rechargeable System

vBloc® Therapy is delivered through the Maestro Rechargeable System, a pacemaker-like implant, and is non-invasively programmed by a physician to best meet the individual patient's needs. Unlike the majority of existing surgical obesity treatments, normal digestive system anatomy is preserved. It is also intended to reduce the burden related to lifestyle, follow-up and food choice that exists with many available treatments.

vBloc® Therapy offers the following benefits, which may lead to its adoption as the surgical therapy of choice for obesity:

  • Favorable Safety Profile

    • The safety record of the Maestro System is well established: no therapy-related serious adverse events and no long-term effects have been reported across the entire study population.

    • Results from clinical studies have demonstrated excellent cardiovascular safety results.

    • The Maestro System has been implanted in more than 600 patients to date, some out to five years.
       

  • Successful and Sustained Weight Loss

    • vBloc® Therapy reduces hunger feelings between meals and promote earlier fullness during meals to drive successful weight loss.

    • Patients receiving more than 12 hours of vBloc® Therapy per day achieve approximately Ov er 25 percent average excess weight loss (EWL) at 12 months (Met Life)
      method). (
      see EMPOWER™ Trial)

    • Clinical studies have demonstrated clinically significant, sustained weight loss, as well as patient acceptance of, and long-term commitment to treatment.
       

  • Positive vs. Punitive Path

    • vBloc® Therapy addresses the lifelong challenge of obesity without compromising safety, nutrition, lifestyle, or undergoing irreversible anatomical disfigurement.

      • vBloc® Therapy does not require a pre- or post-implant diet, and patients are able to eat normal, healthy meals without food restrictions.

      • vBloc® Therapy minimizes side-effect and follow-up burden.

      • No surgical alteration of the anatomy of the stomach or intestines is required with vBloc® Therapy.

      • The Maestro System can be deactivated, reactivated or completely removed if desired.

    • Patients maintain control of their lifestyle, while being supported in their effort to lose weight safely. With vBloc® Therapy, many social environments that are otherwise inaccessible are comfortable and available to the individual, making it easier to accept and commit to long-term treatment.
       

  • Effect on Diabetes and Hypertension

    • EnteroMedics believes its proprietary vBloc® Therapy has the potential to be effective in the treatment of diabetes and hypertension and is currently conducting a clinical trial to determine its effects on these obesity-related co-morbidities.

Risks of vBloc® Therapy and the Maestro Rechargeable System

The implantation procedure and usage of the Maestro Rechargeable System carry some risks, such as the risks generally associated with laparoscopic procedures as well as the possibility of device malfunction. Adverse events related to the therapy, device, or procedure may include, but are not limited to: pain, heartburn, constipation, nausea, depression, diarrhea, infection, organ or nerve damage, surgical explant or revision, device movement, device malfunction and allergic reaction to the implant.