Therapy Information

Activa®Therapy

Now approved for advanced Parkinson's disease, Activa Parkinson's Control Therapy is a safe and effective adjunctive treatment option for many Parkinson's patients. Activa Therapy controls rigidity, bradykinesia/akinesia and/or tremor - while reducing the duration of dyskinesia related to antiparkinsonian medication. ^1,2,3

References:
1. Data on file at Medtronic, Inc.
2. Limousin P, Krack P, Pollak P, et al. Electrical stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 1998;339:1105-11.
3. 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.
4. Deuschl G, Fogel W, Hahne M et al. Deep brain stimulation for Parkinson's disease. J Neurol 2002; 249:III/36-III/39

Advantages of Activa® Parkinson's Control Therapy Activa Therapy can provide more than six additional hours of relief from the debilitating bradykinesia/akinesia, rigidity and/or tremor of Parkinson's disease. It can also reduce the duration of the dyskinesias that are a common side effect of Parkinson's medications.1 Reversible Unlike both pallidotomy and thalamotomy, Activa Therapy is a fully reversible,non-lesioning ,that does not damage brain tissue 2.3.4. The system may be removed - preserving options for future therapies.

Adjustable As the disease evolves, so will treatment requirements. The stimulation parameters of the Activa Therapy neurostimulation system can be quickly and easily adjusted by the physician and the patient (within physician set limits) to maximize symptom control. N'Vision T is a pocket-sized, user friendly, non invasive programmer for the management of all Medtronic neuromodulation devices AccessT therapy patient controller empowers patients with more control over their disease management (within physician-set and locked parameters), reducing dependence on the medical community 5

Bilateral
Unlike Pallidotomy and thalamotomy, Activa therapy, via a single KinetraT neurostimulator, can be implanted to treat unilateral and expanded to bilateral treatment as dictated by disease evolution. ^6,7,8

Activa therapy has a reassuring safety profile

• Activa therapy is well tolerated - the majority of side-effects are usually mild and transient in nature ^6,9, and can often be easily managed by adjusting the stimulation parameters ²
• The majority of patients recover quickly and experience little discomfort during the healing process
• The risk of potential surgical complications with Activa Therapy is similar to those encountered with other stereotactic neurosurgical procedures ^6,10,11
• There is no damage to the brain tissue as a result of Activa Therapy
• Activa Therapy has been shown to be cognitively safe ^{12, 13}

References:
1 Data on file at Medtronic, Inc.
2 Pollak P, Fraix V, Krack P et al. treatment results: Parkinson's disease. Mov Disord 2002; 17:S75-
3 Ardouin C, Pillon B, Peiffer E, et al. Bilateral subthalamic or pallidal stiumulation for Parkinson's
4 Haberler C, Alesch F, Mazal PR, et al. No tissue damage by chronic deep brain stimulation in Parkinson's disease. Ann Neurol. 2000; 48:372-376.
5 Vesper J, Chabardes S, Fraix V et al. Dual channel deep brain stimulation system (kinetra) for Parkinson's disease and essential tremor: a prospective multicentre open label clinical study. J Neurol Neurosurg Psychiatry 2002 ; 73 :275-280
6 Limousin P, Speelman JD, Gielen F et al. Multicentre European study of thalamic stumulation in parkinsonian adn essential tremor. J Neurol Neurosurg Psychiatry 1999; 66: 289-296
7 Medtronic Global clinical study report : Activa Parkinson's disease control therapy (N1-3169). 1999
8 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.
9 Molinuevo JL, Valldeoriola F, Tolosa E et al. Levodopa withdrawal after bilateral subthalamic nucleus stimulation in advanced Parkinson disease. Arch Neurol 2000; 57: 983-988
10 Deuschl G, Fogel W, Hahne M et al. Deep brain stimulation for Parkinson's disease. J Neurol 2002; 249:III/36-III/39
11 Schuurman PR, Bosch DA, Bosch DA, Bossuyt PMM et al. A comparison of continuous thalamic stimulation and thalamotomy for suppression of severe tremor. New Eng J Med 2000; 342: 461-468
12 Ardouin C, Pillon B, Peiffer E, Benabid AL et al. Bilateral subthalamic or pallidal stimulation for Parkinson's disease affects neither memory nor executive functions: a consecutive series of 62 patients. Ann Neurol 1999; 46: 217-223
13 Troster Al, Pahwa R et al.Neuropsychological and quality outcome after thalamic stimulation for essential tremor. Neurology 1999; 53: 1774 - 1780

History of Deep Brain Stimulation
Neurologists and neurosurgeons have used electrical stimulation since the 1960s as a way to locate and distinguish specific sites in the brain. During the process, they discovered that stimulation of certain brain structures suppresses the symptoms of neurological disorders such as essential tremor and Parkinson's disease. Medtronic developed brain stimulation technology in the 1980s in conjunction with leading physician researchers. In 1987, professors Alim-Louis Benabid and Pierre Pollak of the University of Grenoble in France published the results of the first application of chronic deep brain stimulation for the treatment of movement disorders.

• Activa Parkinson's Control Therapy, which has been approved in Canada, Europe and Australia since 1998 and in the United States since January 2002, extends the use of Medtronic's brain stimulation technology to benefit patients with advanced, levodopa-responsive Parkinson's disease. Activa Parkinson's Control Therapy targets the subthalamic nucleus (STN) or the globus pallidus interna (GPi) to suppress some of the disabling symptoms of Parkinson's disease.
• Activa Tremor Control Therapy, which has been approved in Canada, Europe and Australia since 1995 and in the United States since 1997, targets the ventral intermediate nucleus (VIM) of the thalamus to suppress tremor associated with essential tremor or Parkinson's disease.

The History of Deep Brain Stimulation for the Treatment of Movement Disorders
Electrical stimulation of the brain has been used since 1987 to treat movement disorders. Today over 20000 people worldwide have benefited from the Medtronic deep brain stimulation technology called Activa Therapy for essential tremor and advanced Parkinson's disease.

* Benabid AL, Pollak P, Louveau A et al. Combined thalamotomy and stimulation stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson's disease. Appl Neurophysiol 1987; 50: 344-346