Least Invasive

maestro VBLOC Therapy

 

The Maestro® Rechargeable System consists of a subcutaneously implanted rechargeable neuroregulator and two electrodes that are laparoscopically implanted typically in a 60-90 minute procedure.



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 Rechargeable System is recharged using an external mobile charger and transmit coil worn by the patient. The device is non-invasively programmed to best meet the individual patient's needs, and it can be adjusted, deactivated, reactivated or completely removed if desired.

 

Components


The major components of the Maestro Rechargeable 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.

 

Implantation Procedure


The Maestro Rechargeable System is implanted by a bariatric surgeon using a procedure that is typically performed within 60-90 minutes. 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 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.

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