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Activa PC Neurostimulator

Deep Brain Stimulation

  • Activa PC Neurostimulator for Deep Brain Stimulation

Product Overview

The Activa™ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation with a single device. Activa PC contains a nonrechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.

INDICATIONS

MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE

Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson's disease of at least 4 years' duration that are not adequately controlled with medication, including motor complications of recent onset (from 4 months to 3 years) or motor complications of longer-standing duration.

MEDTRONIC DBS THERAPY FOR TREMOR

Unilateral thalamic stimulation of the ventral intermediate nucleus of the thalamus (VIM) using Medtronic DBS Therapy for Tremor is indicated 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.

MEDTRONIC DBS THERAPY FOR EPILEPSY

Bilateral stimulation of the anterior nucleus of the thalamus (ANT) using the Medtronic DBS System for Epilepsy is indicated as an adjunctive therapy for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to three or more antiepileptic medications.

The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per month over the three most recent months prior to implant of the DBS system (with no more than 30 days between seizures). The Medtronic DBS System for Epilepsy has not been evaluated in patients with less frequent seizures.

MEDTRONIC DBS THERAPY FOR DYSTONIA*

Medtronic DBS Therapy for Dystonia is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis), in patients 7 years of age or above.

Medtronic Reclaim DBS Therapy FOR OBSESSIVE-COMPULSIVE DISORDER*

The Medtronic Reclaim™ DBS Therapy is indicated for 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).

PRODUCT DETAILS

MR CONDITIONAL

Medtronic gives you the first safe† access to MRI anywhere on the body for diagnosing health conditions in DBS patients. Eligible patients with an Activa PC neurostimulator may have an MRI scan anywhere on the body under certain conditions. Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems and DBS MRI Eligibility Sheet for a complete list of conditions and instructions for use (available on the Medtronic Manual Library).

ACCESS MRI RESOURCES

ADVANCED PROGRAMMING

  • Establish programming groups that may allow patients to reach optimized settings sooner.
  • Achieve finer control over the stimulation field by delivering multiple programs per lead.

DEVICE STORAGE

Patient-specific data — including historical settings and therapeutic response — is stored in the neurostimulator for easy access from the clinician programmer.

COMPATIBLE PRODUCTS

  • Lead model 3387 – movement disorders and epilepsy
  • Lead model 3389 – movement disorders and epilepsy
  • Lead model 3391 – psychiatric disorders
  • Extension model 37086
  • DBS tunneling tool model 3755
  • Stimloc™ lead anchoring device
  • Clinician programmer model CT900 (tablet) with ActivaTM clinician programmer application model A610, and communicator 8880T2
  • N'Vision™ clinician programmer model 8840 – movement disorders and psychiatric disorders
  • DBS patient programmer model 37642 – movement disorders and psychiatric disorders
  • DBS InterceptTM patient programmer model 37441 – epilepsy

MANUALS AND TECHNICAL GUIDES

Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library. Search by the product name (Activa PC) or model number (37601). You may also call 800-961-9055 for a copy of a manual.

MODEL SPECIFICATIONS

Model 37601
Battery Type Primary Cell
Weight 67 g (2.4 oz)
Height 65 mm (2.6 in)
Length 49 mm (1.9 in)
Channels 2
*

Humanitarian Device: Medtronic DBS Therapy has been authorized by Federal Law for the use as an aid in the management of chronic, intractable (drug refractory) primary dystonia and for people with chronic, severe, treatment-resistant obsessive-compulsive disorder. The effectiveness of this device for these uses has not been demonstrated.

†

Medtronic DBS systems are MR Conditional and safe in the MR environment as long as certain conditions are met. If the conditions are not met, a significant risk is tissue lesions from component heating, especially at the lead electrodes, resulting in serious and permanent injury including coma, paralysis, or death. Refer to the MRI Guidelines for Medtronic Deep Brain Stimulation Systems for a complete list of conditions.