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Overview

 
 

Obesity

 
 

About vBloc® Therapy

 
 

vBloc® Maestro® System

 

Clinical Experience

 
 

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Maestro System
Components
Potential Benefits of vBloc® Therapy and the Maestro System
Use of the Maestro System


Maestro System

The Maestro® System consists of a subcutaneously implanted rechargeable neuroregulator and two electrodes that are laparoscopically implanted by a bariatric surgeon. It delivers VBLOC® vagal blocking therapy via these electrodes that are placed in contact with the trunks of the vagus nerves just above the junction between the esophagus and the stomach. The device intermittently blocks vagal nerve signals throughout the patient’s waking hours. The Maestro System is recharged using an external mobile charger and transmit coil worn by the patient. The device can be non-invasively programmed, and it can be adjusted, deactivated, reactivated or completely removed if desired.

EnteroMedics® has significant experience with vBloc® Therapy; more than 600 patients have been implanted with the Maestro System to date, some out to five years. Data on safety, efficacy and sustained weight loss with vBloc® Therapy is being collected in multiple clinical trials.

Components

The major components of the Maestro System include:

  • Neuroregulator. The neuroregulator, sometimes referred to as a neuroblocking pulse generator, is an implanted device that controls the delivery of vBloc® Therapy to the vagus nerve. It is surgically implanted just below, and parallel to, the skin, typically on the side of the body over the ribs.

  • Lead System. Proprietary leads are powered by the neuroregulator and deliver electrical pulses to the vagus nerve via the electrodes. The leads and electrodes are similar to those used in traditional cardiac rhythm management products.

  • Mobile Charger. The Mobile Charger is an electronic device worn by the patient externally while recharging the device. It connects to the transmit coil and provides information on the battery status of the neuroregulator and the Mobile Charger.

  • Transmit Coil. The Transmit Coil is positioned for short periods of time over the implanted neuroregulator to deliver radiofrequency battery charging and therapy programming information across the skin into the device.

  • 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.

Potential Benefits of vBloc® Therapy and the Maestro System

vBloc® Therapy is delivered through the Maestro System, a pacemaker-like implant, and is non-invasively programmed by a physician to best meet the individual patient’s needs. It ialso can be adjusted, deactivated, reactivated or completely removed if desired. The implantation of the Maestro System does not alter normal digestive system anatomy. It also allows for a normal diet and lifestyle.

The Maestro Rechargeable System has received Food and Drug Adminstration (FDA) approval as well as CE Mark in Europe, and has been listed on the Australian Register of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration (TGA) for supply in Australia.

Use of the Maestro System

The physician activates the Maestro System after implantation. vBloc® Therapy then delivers therapy intermittently as programmed by the physician. The scheduled delivery of the intermittent blocking of the vagus nerve is customized for each patient.