1. Instrument of Change

2. Activa Therapy: Improving Motor Function for Movement Disorder Patients
Double click box to play video

3. Activa Therapy Overview Approved Indications for Activa Therapy
Parkinson’s disease
Essential Tremor
Dystonia
Surgical Procedure
Patient Management
Coding and Reimbursement
Activa in Your Practice

4. Activa Therapy: Overview

5. Activa Therapy Also known as deep brain stimulation, or DBS
Uses an implanted electrode to deliver high-frequency electrical stimulation to structures involved in the control of movement within either the:
Ventral intermediate nucleus of the thalamus (Vim)
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
Double click image to play video

6. Approved Indications
Activa Therapy is approved for the treatment of symptoms due to:
Essential Tremor
FDA approved in 1997
Parkinson’s disease
FDA approved in 2002
Dystonia
FDA approved (HDE*) in 2003
Over 30,000 patients implanted worldwide
*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.

7. Target Sites for Activa Therapy
Vim Thalamus: Essential Tremor
Subthalamic Nucleus: Parkinson’s disease and Dystonia
Globus Pallidus: Parkinson’s disease and Dystonia

8. Activa Therapy: Implantable Components
Lead
Extension
Neurostimulator (implantable pulse generator)
Soletra™
Single Channel Output
Kinetra®
Dual Channel Output

9. External Components 8840 N’Vision® Clinician Programmer
Access™ Patient Controller
Access™ Review Patient Controller

10. Activa Therapy: Parkinson’s Disease

11. Parkinson’s Disease
Progressive neurodegenerative disorder with the cardinal features of:
Bradykinesia/akinesia
Tremor
Rigidity
Postural instability
Second most common neurodegenerative disorder, affecting more than 1 million Americans

12. Treatments for PD Pharmacological treatments Supplemental therapies
Physical therapy
Speech therapy
Environmental modification
Surgical interventions
Activa Therapy (DBS)
Ablation

13. Activa Therapy Improves Some of the Cardinal Motor Features of PD
Double click box to play video

14. Parkinson’s Disease Treatment: Continuum of Interventions
Signs of levodopa “wearing-off”
Dyskinesia, “On-Off” Motor Fluctuations
Postural Instability, Freezing, Falls, Dementia
DBS
Mild Moderate Severe
Levodopa, COMT inhibitors, others
Treatment
Patient Symptoms
Disease Severity
Agonists
Modified from Giroux, ML and Farris, SF. Cleveland Clinic Foundation 2005
Cleveland Clinic Foundation
Center for Neurological Restoration

15. Activa Therapy: When Pharmacotherapy isn’t Enough
As Parkinson’s disease progresses, medications may fail to provide consistent and adequate symptom control
Medications used at levels required for symptom control may produce adverse effects
Motor complications, such as dyskinesia
Cognitive and psychiatric problems
Nausea, hypotension, and other systemic effects

16. When Should Activa be Considered?
When, despite optimized pharmacotherapy, your patient experiences troubling motor symptoms, which may include:
Wearing off – Off periods that contain troubling bradykinesia, rigidity, tremor, and/or gait difficulty
Troubling dyskinesia
Motor fluctuations
Refractory tremor

17. Exclusion Criteria for Activa
Atypical (non-idiopathic) parkinsonism
Lack of sustained response to levodopa
Frank dementia, moderate to severe dementia
Most Activa Implanting Centers will review patient medical history to identify other potential exclusion criteria & verify patient candidacy for Activa.

18. Two Questions to Ask Your Patient:
“How many hours a day do your symptoms bother you?”
“Are you satisfied?”
If they aren’t satisfied with their symptom control using existing therapy, Activa should be considered

19. 6 Months After Surgery Bilateral STN Activa® Implant
“ON” Time Without Dyskinesias Improves from 27% to 74% of a Patient’s Waking Day*
27%
19%
49% 7%
74%*
23%
In the prospective, randomised, double-bind, crossover multi-center study conducted by the Deep-Brain Stimulation for Parkinson's Disease Study Group, 96 patients with advanced, drug-refractory PD underwent bilateral stimulation of the STN with Activa® Therapy.
Patients completed a home diary documenting their motor status during the 2 days before each visit. Three motor states were identified: poor mobility (‘Off’), good mobility without dyskinesia (‘On’ without dyskinesia), and good mobility with dyskinesia (‘On’ with dyskinesia).
Assessments of the percentage of time with good mobility and without dyskinesia (‘On’ without dyskinesia) during the waking time increased from 27% at baseline to 74% at six months, a 3-fold gain. This was paralleled by a decrease in the percentage of time with poor mobility (‘Off’ state), from 49% to 19%.
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.
PD = Parkinson’s disease; STN = subthalamic nucleus; DBS = deep-brain stimulation
Before Surgery
(n=96)
6 Months After Surgery Bilateral STN Activa® Implant
(n=91)
‘ON’ with Dyskinesia
‘ON’ without Dyskinesia
‘OFF’
* The Deep-Brain Stimulation for Parkinson’s Disease Study Group. Deep-brain stimulation of the subthalamic nucleus for the pars interna of the globus pallidus in Parkinson’s disease. N Eng J Med. 2001;345:

20. Efficacy: Benefits of Activa Therapy Impact on Mobility
Dyskinesia
“On” Time
“Off” Time
This graph is only for illustrative purposes and does not represent actual “on” and “off” time.
Before
After

21. Efficacy: Benefits of Activa Therapy for PD Patient Population
87% of patients demonstrated improved motor scores in the OFF medication state at the 12-month evaluation .*
* Results were for a subset of patients whose data were verified against medical records. Data on file at Medtronic, Inc.

22. Motor Symptoms Improvements Maintained After 5 Years
In a 5-year study, ACTIVA significantly improved OFF-medication assessments of tremor, rigidity, and akinesia/bradykinesia
OFF-Medication Motor Score Improvements*
6-month
1-year
3 years
5 years
Tremor
79%
75%
83%
Rigidity
58%
73%
74%
71%
Akinesia
42%
63%
52%
49%
*Results for STN

23. Additional Benefits of Activa
Bilateral, reversible, and adjustable
Non-destructive versus ablative procedures
Can be non-invasively fine-tuned to each patient’s individual needs

24. Activa Therapy: Potential Complications and Risks
Surgery related
Hemorrhage (inherent in any stereotactic procedure); may be silent or symptomatic
Transient confusion
Infection (typically occurs at neurostimulator site in chest when it does occur)
Stimulation related
Usually can be minimized or eliminated by adjusting stimulation settings
Reversible paresthesia, dysarthria, muscle contraction

25. Activa Therapy: Essential Tremor

26. Essential Tremor
The most common movement disorder, affecting up to 20% of the elderly
Produces postural tremor disorder (may also occur at rest); most commonly affects hands but can also affect head, voice, tongue, and legs

27. Pharmacologic Treatment of ET
Beta-blockers
Antiepileptics
Benzodiazepines
Botulinum toxin injections
Drug-induced adverse effects common

28. Questions to Ask Your Patient:
"How many hours per day do your symptoms bother you?"
“Are you satisfied with your ability to do the things you enjoy?”

29. Video: ET Patient Before & After
Pre-Op
Comparing Pre & Post-Op
Double click box to play video
Double click box to play video

30. Activa Therapy Efficacy for ET
69% of Essential Tremor patients experience total or significant suppression of disabling tremor *
This results in significant reduction in disability
Stimulation-induced adverse effects include transient paresthesia, dysarthria, and disequilibrium
Many of the side effects were temporary or improved with adjustment of electrical parameters
* Data on File. Medtronic, Inc.

31. Essential Tremor Guidelines
Guidelines published by the American Academy of Neurology (AAN) in June 2005 concluded that:
Unilateral DBS resulted in a significant (60 to 90%) reduction of contralateral limb tremor
Zesiewicz TA, Elbe R, Louis ED, et al. Practice Parameter: Therapies for essential tremor. Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2005;64:

32. Activa Therapy: Dystonia

33. Dystonia Video Post-Op Short Term Pre-Op Post-Op Long Term
Double click box to play video
Double click box to play video
Post-Op
Long Term
Double click box to play video

34. Dystonia
Syndrome of sustained muscle contractions, frequently causing twisting and repetitive movements, or abnormal postures
Onset: Mean age = 27, with bimodal incidence peaks at 9 and 40 years of age
Dystonic symptoms may be increased with movement

35. Pharmacologic Treatment of Dystonia
Anticholinergics
Dopaminergic agents
Benzodiazepines
Baclofen
Local injections of botulinum toxin

36. Activa Therapy for Dystonia
Currently approved under Humanitarian Device Exemption (HDE)
*Humanitarian Device Exemption approval for patients 7 years and older

37. Key DBS Literature Parkinson's disease Essential Tremor Dystonia
The Deep-Brain Stimulation for Parkinson’s Disease Study Group. Deep-brain stimulation of the subthalamic nucleus for the pars interna of the globus pallidus in Parkinson’s disease. N Eng J Med. 2001;345:
Krack P, Batir A, Van Blercam N, et al. Five-year follow-up of bilateral stimulation of the subthalamic nucleus in advanced Parkinson’s disease. N Eng J Med. 2003;349:
Essential Tremor
Koller WC, Lyons KE, Wilkinson SB, et al. Long-term safety and efficacy of unilateral deep brain stimulation of the thalamus in essential tremor. Mov Disord May;16(3):464-8.
Dystonia
Coubes P, Roubertie A, Vayssiere N, et al. Treatment of DYT1-generalised dystonia by stimulation of the internal globus pallidus. Lancet 2000;355:2220

38. Activa Therapy: Surgical Procedure

39. Surgical Technique
Stereotactic frame placement or frameless stereotaxy
Targeting
Imaging
Stereotactic targeting
Physiologic targeting (microelectrode recording and stimulation)
Electrode placement
Pulse generator implantation
Although techniques vary from center to center, the general aspects of the surgery will be described. DBS surgery uses stereotactic neurosurgical techniques to identify the brain targets of interest and to implant the DBS leads into them. Stereotaxis is typically performed by acquiring a brain image using magnetic resonance imaging (MRI) or computed tomography (CT) with a rigid stereotactic frame affixed to the patient’s skull. The surgeon is then able to calculate the three-dimensional targets of interest in the brain with relation to the x, y, and z coordinates marked on the stereotactic frame. This frame and the arc mounted to it then allows instruments and the DBS lead to be precisely guided to the brain target. This is accomplished, typically using local anesthesia, through an incision in the scalp and burr holes in the skull.

40. Surgical Technique: Targeting
Sophisticated imaging and software enables precise targeting for optimal outcomes and minimal risk
Microelectrode recording (MER) offers additional levels of verification of lead location

41. Surgical Technique: Microelectrode Recording
Border
10sec
Sagittal Section Through the Thalamus
80ms
STN
10sec
80ms
Border/SN
10sec
80ms

42. Surgical Technique: DBS Lead Placement
Leads placed in motor territory of nucleus
Leads have four electrodes
Multiple electrode configurations possible during post-operative programming

43. Target Sites for Activa Therapy
Vim Thalamus: Essential Tremor
Subthalamic Nucleus: Parkinson’s disease and Dystonia
Globus Pallidus: Parkinson’s disease and Dystonia

44. Surgical Technique: Neurostimulator Placement
Can be done immediately or days/weeks later
Typically placed below clavicle
Connected to lead using extension

45. Activa Patient Management

46. Adjustability of Activa Therapy
Non-invasive adjustment of parameters to maximize benefit and minimize adverse effects
Selection of electrodes allows adjustment of the site of stimulation
Adjustment of parameters allows control over amount of therapy
Adjustments generally are few once optimal parameters are achieved

47. Coding & Reimbursement

48. Commonly Billed Codes Neurologist
Physician Coding & Reimbursement for Programming
Code
Description
2005 Medicare National Avg. in Office Setting
2005 Medicare National Avg. in Outpatient Setting
95970
Electronic analysis of IPG, without reprogramming
$50.40
$23.50
95978*
Electronic analysis of deep brain IPG with programming, 1st hour
$212.60
$188.73
95979*
Electronic analysis of deep brain IPG with programming, each add’l 30 minutes after 1st hour
$98.15
$91.33
*CPT & are reassigned to CPT & for 2005, specifically for the analysis & reprogramming of a deep brain neurostimulator pulse generator.
2005 Medicare National Payment based on 2005 Medicare RVUs and conversion factor ($ ) as published in the November 3, 2004 Federal Register. Individual physician reimbursement will vary.

49. High Volume Neurology Codes
Description
2005 Medicare Fee Schedule
Average Time (minutes)
Revenue per Hour
Procedures
95903
Motor NCT
$69.73
30-60
$70-139
95816
EEG
$187.59 $
95860
Needle EMG
$92.85
15-30 $
95974
VNS Programming and Analysis
$184.56
10-20 $
95978
DBS Programming and Analysis
$212.61
15-60 $
This table compares revenue and time utilization for high volume neurology patient care and codes. The time and revenue will vary based on variances in clinical practice.

50. Activa in Your Practice
Establish how you want to work with the Activa center in your area
Partner with Medtronic to develop a training program for you and your staff
Identify, educate, and refer appropriate patients

51. Working with the Activa Center
Become familiar with the center where you will refer patients for Activa Therapy
Your Medtronic Therapy Consultant will assist you in meeting members of the local Activa center
Determine your desired role in working with Activa patients
Participate in post-implant management of Activa Therapy (programming the device)
Refer for implant, with Activa center managing stimulation programming; continue to manage non-Activa issues
View an Activa Therapy system surgical implant or programming clinic

52. Training for You and Your Staff
Partner with Medtronic for a full range of educational opportunities designed to further your therapeutic success
Medtronic Activa Therapy’s Curriculum For Life provides the framework to support your professional growth as you develop and expand your expertise
Building a Curriculum and
Designing a Pathway for Success
Toward Lifelong Learning

53. Identify, Educate, and Refer Appropriate Patients
Medtronic can support you with patient education materials
Activa Ambassador
Gives patients the opportunity to consult and interact with an implanted patient
Introduction to Activa Event
Physician-directed patient events designed to identify Activa candidates

54. Activa Therapy is Rewarding
Sooner Can be Better than Later
“…stimulation therapy should be considered before the development of a major disability that threatens their employment and their roles in their family and in society.”
AE Lang. Subthalamic Stimulation for Parkinson’s Disease – Living Better Electrically? N Engl J Med 2003;

55. Disclosure Statement/Contraindications
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. 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) by the Medtronic Activa System is indicated 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.
Contraindications: Contraindications include patients who will be exposed to MRI using a full body radio-frequency (RF) coil or a head transmit coil that extends over the chest area, patients who are unable to properly operate the neurostimulator, or for Parkinson’s disease and Essential Tremor, patients for whom test stimulation is unsuccessful. Also, diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy) is contraindicated because diathermy's energy can be transferred through the implanted system (or any of the separate implanted components), which can cause tissue damage and can result in severe injury or death. Diathermy can damage parts of the neurostimulation system.

56. Disclosure Statement/Contraindications
Warnings/ Precautions/Adverse Events: There is a potential risk of tissue damage using stimulation parameter settings of high amplitudes and wide pulse widths. Extreme care should be used with lead implantation in patients with a heightened risk of intracranial hemorrhage. Do not place the lead-extension connector in the soft tissues of the neck. Placement in this location has been associated with an increased incidence of lead fracture. Theft detectors and security screening devices may cause stimulation to switch ON or OFF, and may cause some patients to experience a momentary increase in perceived stimulation. Although some MRI procedures can be performed safely with an implanted Activa System, clinicians should carefully weigh the decision to use MRI in patients with an implanted Activa System. MRI can cause induced voltages in the neurostimulator and/or lead possibly causing uncomfortable, jolting, or shocking levels of stimulation. MRI image quality may be reduced for patients who require the neurostimulator to control tremor, because the tremor may return when the neurostimulator is turned off.
Severe burns could result if the neurostimulator case is ruptured or pierced. The Activa System may be affected by or adversely affect medical equipment such as cardiac pacemakers or therapies, cardioverter/defibrillators, external defibrillators, ultrasonic equipment, electrocautery, or radiation therapy. Safety and effectiveness has not been established for patients with neurological disease other than Parkinson’s disease or Essential Tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; or for patients who are pregnant, under 18 years, over 75 years of age (Parkinson’s Control Therapy) or over 80 years of age (Tremor Control Therapy). For patients with Dystonia, age of implant is suggested to be that at which brain growth is approximately 90% complete or above. Additionally, the abrupt cessation of stimulation for any reason should be avoided as it may cause a return of disease symptoms. In some cases, symptoms may return with an intensity greater than was experienced prior to system implant (“rebound” effect). Adverse events related to the therapy, device, or procedure can include: stimulation not effective, cognitive disorders, pain, dyskinesia, dystonia, speech disorders including dysarthria, infection, paresthesia, intracranial hemorrhage, electromagnetic interference, cardiovascular events, visual disturbances, sensory disturbances, device migration, paresis/asthenia, abnormal gait, incoordination, headaches, lead repositioning, thinking abnormal, device explant, hemiplegia, lead fracture, seizures, respiratory events, and shocking or jolting stimulation.
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 (torticollis), for individuals 7 years of age and older.