Kinetra for Deep Brain Stimulation

Kinetra for Deep Brain Stimulation

 

 

Specifications for Kinetra, Model 7428

Height 2.4 in. (61 mm)
Length 3.0 in. (76 mm)
Thickness 0.6 in. (15 mm)
Weight 2.8 oz (83 g)
Volume 3.1 in3 (51 cm3)
Battery Life 2-5 years for movement disorders, 6-16 months for OCD
Rate 66 settings, 3-250 Hz (pps); 30 values above 130 Hz
Pulse Width 14 settings, 60 - 450 μsec
Amplitude 0 to 10.5 V in increments of 0.1 V
Rechargeable No
Programs 2
Extensions Required
Cycling OFF/ON: 0.1 s to 24 hours

Features

  • Simplified implantation and fewer incisions required, with only one neurostimulator needed for bilateral intervention
  • Programming options that help prevent electromagnetic fields from inadvertently shutting off the neurostimulator
  • Gradual decrease in battery capacity, for better replacement planning
  • More voltage and rate settings, for fine-tuning patient intervention
  • SoftStart/StopTM mode for smoother transitions
  • Day-cycling mode that automatically turns the neurostimulator off at night
  • Ability to disable magnetic reed switch to prevent inadvertent shut-off from electromagnetic fields

Indications

Parkinson's Control Therapy:

Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.

Obsessive-Compulsive Disorder Therapy*::

Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).

* Humanitarian Device: The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated.

References

  1. Activa Therapy Clinical Summary, 2003.

How Kinetra Works

The Kinetra neurostimulator works through 2 channels to deliver bilateral intervention with a single device.

Kinetra contains a battery and microelectronic circuitry for controlled electrical pulse generation. The device is typically implanted subcutaneously near the clavicle. It generates electrical signals that get delivered by the extensions and leads to the targeted structures deep within the brain. Deep brain stimulation using the Kinetra neurostimulator was approved in 2003 for the treatment of symptoms due to Parkinson's disease and in 2009 it received an Humanitarian Device Exemption (HDE) for obsessive-compulsive disorder (OCD).*

For Parkinson's Disease

Kinetra uses an implanted electrode to deliver electrical stimulation to structures involved in the control of movement within the:

  • Subthalamic nucleus (STN)
  • Globus pallidus (GPi)

This electrical stimulation overrides abnormal neuronal activity within these brain regions to bring motor controlling circuits into a more normal state of function, thereby reducing movement disorder symptoms

The stimulation may control rigidity, bradykinesia/akinesia and/or tremor, while reducing the duration of dyskinesia related to antiparkinsonian medication.2

 

For Obsessive-Compulsive Disorder*

Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs).

DBS for OCD delivers electrical stimulation bilaterally to targeted cells in the anterior limb of the internal capsule (AIC), more specifically, the ventral capsule/ventral striatum (VC/VS).

Reclaim™ DBS Therapy for OCD is limited to use in implanting centers that receive Institutional Review Board approval for the procedure.

Reclaim DBS Therapy for OCD has been approved by the FDA under a Humanitarian Device Exemption (HDE)* for the treatment of chronic, severe, treatment-resistant OCD as an alternative to anterior capsulotomy.

Deep brain stimulation is:

  • Reversible—Unlike lesion procedures such as pallidotomy and thalamotomy, deep brain stimulation (DBS) is reversible. The system components may be completely removed, preserving options for future therapies1,2
  • Adjustable—Using a non-invasive clinical programmer, you can fine-tune stimulation parameters to maximize therapeutic benefit and minimize side effects 1,2
  • Safe and effective—DBS has consistently demonstrated a high level of reliability, and the intervention is typically well-tolerated1,2

* Humanitarian Device: The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated.

References

  1. Activa Therapy Clinical Summary, 2003.
  2. The Deep-Brain Stimulation for Parkinson's Disease Study Group. Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med. 2001;345:956-63.