Programmer & Accessories

Programming System

The latest release of the VNS Therapy™ Programming System consists of a wireless Programming Wand, Model 2000 and a touchscreen Programmer, Model 3000 preloaded with the VNS Therapy Software.

The Programmer and Wand connect wirelessly and allow you to:

Interrogate (communicate with) the generator in order to adjust therapy parameters
Assess generator and lead function
View device histories
Export session reports

The Programmer, Model 3000 and Wand, Model 2000 are compatible with the latest VNS Therapy generator (Model 1000 SenTiva™ and Model 1000-D SenTiva DUO™) and generator Models 102-106.

For more on how to use the VNS Therapy Programming System, visit the Physician Manuals page.

Implantable Leads

The VNS Therapy^™ System uses a silicone-insulated lead to deliver the electrical signal from the pulse generator to the left vagus nerve. The latest generation of implantable leads includes the PerenniaDURA^™ and PerenniaFLEX^™.

The PerenniaDURA, Model 303 lead offers greater reliability with 17-times greater durability over previous LivaNova leads tested.
The PerenniaFLEX, Model 304 lead combines the flexible handling characteristics of earlier device models with 3.5-times greater durability.

The leads are bifurcated at one end, with two helical electrodes and an anchor tether, which are coiled around the vagus nerve. The other end has a single connector pin, which is tunneled subcutaneously to the chest pocket and inserted into the pulse generator. The leads are available in two sizes (2.0 mm and 3.0 mm) to accommodate different nerve sizes and ensure optimal fit.

Tunneler

The VNS Therapy™ Tunneler, Model 402 is a single-use surgical tool used to subcutaneously tunnel the lead connector and body from the neck incision site to the generator in the chest pocket. It is compatible with all VNS Therapy Leads.

The Tunneler package contains four basic components: a stainless steel shaft, two fluorocarbon polymer sleeves (one small-diameter, one large-diameter), and a stainless steel bullet tip. If necessary, the Tunneler can be manually shaped (≤25 degrees) to help direct it through the body.

Accessory Pack

The VNS Therapy™ Accessory Pack, Model 502 contains replacements for components of the lead and generator that may become unusable during routine surgery.

Each pack includes:

Hex screwdriver: used to adjust the generator setscrew(s) and to allow the escape of back pressure created by lead insertion. A hex screwdriver is also provided with the pulse generator.
Resistor assemblies (single and dual pin): used to perform the optional Generator Diagnostics (Pre-Implant Test) in cases of troubleshooting to verify that the generator is functioning properly, independent of the lead.
Four tie-downs: used to secure the lead to fascia during implantation and to help form the strain-relief bend and loop. Tie-downs are also supplied with the leads.

Patient Essentials Kit

The Patient Essentials Kit, Model 220 is provided to the patient or caregiver after the VNS Therapy implant procedure. The kit contains:

Two VNS Therapy Magnets: can be used to provide on-demand stimulation as an attempt to abort or deintensify a seizure, temporarily inhibit stimulation, verify generator functioning, or reset the generator (in combination with the programming system).
Magnet accessories: one belt clip to wear the magnet pager-style and one wristband to wear the magnet watch-style
Patient Information cards: contains information about the VNS Therapy System that patients should carry with them at all times
Epilepsy Patient Manual

VNS Therapy™ has proven safety and tolerability profile with side effects reducing over time

Safety Profile

VNS Therapy^™ has no drug interactions and does not cause drug-related toxic central nervous system side effects.

Common side effects include hoarseness or change in voice tone, shortness of breath, sore throat, and coughing. Most side effects associated with VNS Therapy occur only during stimulation, tend to diminish over time, or are eliminated by adjusting parameter settings.

The most common side effect of the surgical procedure is infection. Children under 12 may have a greater risk of infection than those 12 years of age and older and may be more likely to experience lead damage due to higher activity levels and the potential to manipulate the lead.

For more safety information click here.