Soletra for Deep Brain Stimulation

Specifications for Soletra, Model 7426

Height	2.2 in. (55 mm)
Length	2.4 in. (60 mm)
Thickness	0.4 in. (10 mm)
Weight	1.5 oz (42 g)
Volume	8.7 in3 (22 cm3)
Battery Life	2-5 years for movement disorders, 6-16 months for OCD
Rate	28 settings, 2-185 Hz (pps) - 5 values above 130 Hz
Pulse Width	10 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

• Non-invasive adjustment of parameters
• Selection of electrodes to allow adjustment of the site of stimulation
• Adjustment of parameters to give clinicians control over amount of intervention
• Few adjustments once optimal parameters are achieved

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.

Tremor Control Therapy:

Unilateral thalamic stimulation for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. The safety or effectiveness of this therapy has not been established for bilateral stimulation.

Dystonia Therapy*:

Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older.

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).

How Soletra Works

The Soletra neurostimulator works through a single channel. Two Soletra neurostimulators are required for bilateral intervention.

Soletra 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 extension and lead to the targeted structures deep within the brain.

Deep brain stimulation using the Soletra neurostimulator is approved for the treatment of symptoms due to:

• Parkinson's disease (FDA approved in 2002)
• Essential tremor (FDA approved in 1997)
• Dystonia (FDA approved (HDE*) in 2003)
• Obsessive-compulsive disorder (OCD) (FDA approved (HDE*) in 2009)

For Parkinson's Disease

The neurostimulators deliver controlled electrical stimulation through bilaterally implanted electrodes to targeted cells in the subthalamic nucleus (STN) or internal globus pallidus (GPi).

The stimulation may control rigidity, bradykinesia/akinesia and/or tremor, while reducing the duration of dyskinesia related to antiparkinsonian medication.^1-3

For Essential Tremor

Deep brain stimulation for tremor control was approved in Canada, Europe and Australia in 1995 and in the United States in 1997 for the treatment of essential and Parkinsonian tremor.

It delivers electrical stimulation via a surgically implanted electrode to targeted cells in the left or right ventral intermediate nucleus (VIM) of the thalamus to control tremor symptoms.^1,3

For Dystonia

Deep brain stimulation for dystonia received a Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration in April 2003 as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older.

DBS for dystonia delivers electrical stimulation bilaterally or unilaterally to targeted cells in the internal globus pallidus (GPi) or subthalamic nucleus (STN).⁴

DBS dystonia intervention is limited to use in implanting centers that receive Institutional Review Board approval for the procedure.

*Humanitarian Device: Authorized by Federal Law for the use as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia, for individuals 7 years of age and older.

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.

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