\

Activa RC for Deep Brain Stimulation

Activa RC for Deep Brain Stimulation

Specifications for Activa RC Model 37612

Height 54 mm (2.1 in)
Length 54 mm (2.1 in)
Thickness
Case
Connector
9 mm (0.4 in)
11 mm (0.4 in)
Weight 40 g (1.6 oz)
Volume 22 cc
Battery Life 9 years
Rechargeable Yes
Amplitude 0 - 10.5 V (voltage mode)
0 - 25.5 mA (current mode)
Rate 2 - 250 Hz (voltage mode)
30 - 250 Hz (current mode)
Pulse Width 60 to 450 µs
Number of Defined Groups 1 to 4
Number of Programs per Group 1 to 4
Softstart™ Off, On
Connector Type Octapolar, in-line 2.8-mm spacing
Electrode Configuration Up to 4 electrodes per lead defined as anode, cathode or Off
Case Defined as anode or Off
External Shield Titanium

Rechargeable Battery

  • Longest interval between device replacements- 9 years

Guided Programming

  • Enables a step by step, systematic approach to programming

Advanced Programming

  • Refine therapy delivery
  • Tailor the stimulation field with interleaved pulses
  • Define two stimulation programs per lead
  • Create up to four therapy groups

Innovative DBS Patient Programmer

  • Customize patient involvement with an innovative patient programmer

Current and Voltage Modes

  • Operates with either voltage or current mode

Indications

Parkinson’s Control Therapy:
Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic® Activa® Parkinson’s Control Therapy is indicated 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 by the Medtronic® Activa® Tremor Control System 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.

Refer to the appropriate information for prescribers booklet for contraindications, warnings, precautions, adverse events summary, individualization of treatment, patient selection, use in specific populations, resterilization, and component disposal.

How Activa RC Works

The Activa RC neurostimulator is a dual-channel device capable of delivering bilateral stimulation.

Activa RC contains a rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subclavicularly, and connected to an extension, and leads which are implanted in the brain.

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

  • Parkinson's disease
  • Essential tremor

Automatically Record Patient Information with Guided Profile

During the first interrogation of Activa RC Guided Profile will automatically prompt the clinician to record:

  • Device model, location, and implantation date
  • Lead model numbers, locations, and configurations
  • Patient’s name and diagnosis
  • Physician information
  • Patient symptoms, location, and whether symptoms occur on or off of medication
  • Tremor with and without stimulation
  • Two physician-defined notes fields

Guided Programming

  • Menu-driven prompts systematically steps through initial and follow-up programming sessions.
  • The neurostimulator stores therapeutic effects and side effects associated with up to 64 combinations of the following parameters:
  • Active electrodes
  • Pulse width
  • Amplitude
  • Rate
  • Summarizes and reports parameters that potentially maximize device longevity and therapeutic response

Individualize Therapy Delivery with Programming Groups

  • Create up to four different therapy groups, comprised of 1-4 programs
  • Patients use the icon-driven DBS patient programmer to switch between the groups to select therapy settings that are most effective
  • Provides patients the opportunity to assume a more active role in their therapy

Extensive Data Management Capabilities

  • Transform device programming from a pencil and paper exercise to a device-based medical record.
  • Store patient’s medical history, device parameters, and therapy usage information in the device.
  • Data travels with the patient, ensuring that it’s always available.

 Advanced Programming Options

The Activa RC system provides several programming options for refined therapy delivery including interleaved pulses and Programming Groups.

Tailor the Stimulation Field with Interleaved Pulses

Two pulses with different combinations of active electrodes, amplitudes and pulse widths can be programmed for each lead. The pulses are delivered in an alternating interleaved fashion, which may allow clinicians to overcome targeting challenges through programming.

Example: Interleaved Pulses

The example shown uses two programs on each DBS lead, with all programs in this example in the unipolar mode (bipolar programs or mixtures of unipolar and bipolar programs can be used also). The pulses are delivered: L1, R1, L2, R2.

For Parkinson’s Disease

A neurostimulator delivers controlled electrical stimulation through bilaterally implanted electrodes to targeted cells in the subthalamic nucleus (STN) or internal globus pallidus (GPi). Therapy can be delivered either unilaterally or bilaterally using a single Activa RC.

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 Essential Tremor

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.
  3. Zesiewicz TA, Elble R, Louis ED, et al. Practice paramater: therapies for essential tremor: Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2005;64:2008-2020.

Device Comparison

Activa® RC
Model 37612		 Activa® PC
Model 37601		 Kinetra®
Model 7428		 Soletra®
Model 7426
Activa RC Model 37612 Activa PC Model 37601 Kintetra Model 7428 Soletra Model 7426
Neurostimulator Physical Specifications
  • Height:
    54 mm (2.1 in)
  • Length:
    54 mm (2.1 in)
  • Case thickness: 9 mm (0.4 in)
  • Connector thickness:
    11 mm (0.4 in)
  • Weight:
    40 g (1.6 oz)
  • Volume:
    22 cc
  • Height:
    65 mm (2.6 in)
  • Length:
    49 mm (1.9 in)
  • Case thickness: 15 mm (0.6 in)
  • Connector thickness:
    15 mm (0.6 in)
  • Weight:
    66 g (2.3 oz)
  • Volume:
    39 cc
  • Height:
    61 mm (2.4 in)
  • Length:
    76 mm (3.0 in)
  • Case thickness: 15 mm (0.6 in)
  • Connector thickness:
    15 mm (0.6 in)
  • Weight:
    83 g (2.9 oz)
  • Volume:
    51 cc
  • Height:
    55 mm (2.2 in)
  • Length:
    60 mm (2.4 in)
  • Case thickness: 10 mm (0.4 in)
  • Connector thickness:
    10 mm (0.4 in)
  • Weight:
    42 g (1.5 oz)
  • Volume:
    26 cc
Therapy Specifications
  • Amplitude:
    0 to 10.5 V
    (Voltage mode)
    0 to 25.5 mA
    (Current mode)
  • Pulse Width:
    60 to 450 µs
  • Rate:
    2 to 250 Hz
    (Voltage mode)
    30 to 250 Hz
    (Current mode)
  • Electrodes: 8 electrodes plus case; 4 electrodes per lead
  • Program(s):
    4 per group
  • Group(s): 4
  • Amplitude:
    0 to 10.5 V
    (Voltage mode)
    0 to 25.5 mA
    (Current mode)
  • Pulse Width:
    60 to 450 µs
  • Rate:
    2 to 250 Hz
    (Voltage mode)
    30 to 250 Hz
    (Current mode)
  • Electrodes:
    8 electrodes plus case; 4 electrodes per lead
  • Program(s):
    4 per group
  • Group(s): 4
  • Amplitude:
    0 to 10.5 V
  • Pulse Width:
    60 to 450 µs
  • Rate:
    3 to 250 Hz
  • Electrodes:
    8 electrodes plus case; 4 electrodes per lead
  • Program(s): 2
  • Group(s): 1
  • Amplitude:
    0 to 10.5 V
  • Pulse Width:
    60 to 450 µs
  • Rate: 2 to 185 Hz
  • Electrodes: 4 electrodes plus case
  • Program(s): 1
  • Group(s): 1
Longevity
9 years Dependent on settings and usage Dependent on settings and usage Dependent on settings and usage
Extensions
  • Model 37085
  • Model 37085
  • Model 7482A
  • Model 7482A
Leads
  • Model 3387
  • Model 3389
  • Model 3387
  • Model 3389
  • Model 3387
  • Model 3389
  • Model 3387
  • Model 3389
Implant Depth
Implant depth less than or equal to 1 cm
The efficiency of the recharging is directly affected by the:
  • Location and depth of implant
  • Position of antenna
 Implant depth less than or equal to 4 cm Implant depth less than or equal to 4 cm Implant depth less than or equal to 4 cm
Groups and Programs
Up to 4 programs per group, up to 4 groups (2 programs per hemisphere ; 1 lead per hemisphere)

(only 1 group is active at any given time)		 Up to 4 programs per group, up to 4 groups (2 programs per hemisphere ; 1 lead per hemisphere)

(only 1 group is active at any given time)		 1 program per lead
(1 lead per hemisphere)		 1 program