§ YEARS§ MONTHS § CRITERIA

EVALUATE FOR DBS

4Medtronic DBS Therapy has Expanded FDA Indication for Parkinson’s*

MORE PARKINSON’S PATIENTS MAY BE ELIGIBLE SOONERMedtronic DBS Therapy may now be considered as a therapeutic option for Parkinson’s patients diagnosed for at least 4 years who are experiencing recent onset of motor complications — from 4 months to 3 years — that are not adequately controlled with medication. The therapy continues to be a therapeutic option for those with advanced, longer-standing motor complications. With Medtronic DBS Therapy, you can now refer your Parkinson’s patients sooner — before they become debilitated.

CANDIDATES FOR MEDTRONIC DBS THERAPYPatients may be eligible for DBS Therapy sooner if they meet the criteria:

YOU CAN NOW REFER YOUR PARKINSON’S PATIENTS, SOONER. Contact your Medtronic representative for more information.

RENEW YOUR PATIENT’S LIFE,SOONER.

Parkinson’s Diagnosis for at least 4 years

Levodopa Responsive

Motor Complications not adequately controlled with medication

Motor Complications for a minimum of 4 months or longer-standing

*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 individuals with motor complications of recent onset (from 4 months to 3 years) or with motor complications of longer-standing duration.

EXPANDED INDICATION — RECENT ONSETResearch now shows Medtronic DBS Therapy may be appropriate in individuals who have had levodopa-responsive Parkinson’s disease for at least 4 years, and who are experiencing recent onset of motor complications (from 4 months to 3 years) that are not adequately controlled with medication.

PD DURATION SINCE ONSET

PREVIOUS INDICATION — ADVANCED (Longer-standing)

Research now shows Medtronic DBS Therapy continues to be appropriate for patients with longer-standing motor complications, as in advanced PD, and has no upper age limit restriction as shown in a post-approval Level 1 evidence clinical trial.

QOL +26%DBS showed a statistically significant improvement of 26% in PD related quality of life vs. 1% worsening in patients receiving best medical therapy (BMT) alone (as measured by the Parkinson’s Disease Questionnaire, PDQ-39 Summary Index).1,2

-61% MEDICATION COMPLICATIONSDBS showed a 61% statistically significant reduction compared to a 13% statistically significant increase in BMT alone patients in drug-related complications, including dyskinesias and motor fluctuations.1,2

+53% MOTOR FUNCTION IMPROVEMENT DBS showed a 53% statistically significant improvement in motor skills vs. a 4% improvement in BMT alone as measured by UPDRS III in an off-medication condition.1,2

SERIOUS ADVERSE EVENTS 1% of all patients experienced AEs that were ongoing when the study was completed.1,2

Overall SAEs affect 55.6% of DBS patients as compared to 44.1% of BMT alone patients.1,2

YEAR 4 32YEAR 1 Diagnosis

765 1098 161514 1713*12*11*

*DBS Therapy was typically used 11-13 years after Parkinson’s Diagnosis.3,4,5

ADL +30%DBS showed a 30% statistically significant improvement in various activities of daily living (while in the worst condition) compared to a 12% decline in those receiving BMT alone as measured by UPDRS II.1,2

The Neurostimulation for Parkinson’s Disease with Early Motor Complications, NEJM 2013 study was a randomized, prospective, controlled trial of Medtronic DBS Therapy compared to Best Medical Therapy (BMT) at 24 months for Parkinson’s disease. The research provides evidence that clinicians no longer have to delay consideration of Medtronic DBS Therapy until the disease has become debilitating.

RECENT ONSETDBS (STN) + BMT at 24 Months

REFERENCES

1. Schuepbach WMM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson’s disease with early motor complications. N Engl J Med. February 14, 2013;368:610-22.

2. Medtronic DBS Therapy for Parkinson’s Disease and Essential Tremor Clinical Summary. M197935A010. 3. Deuschl G, Schade-Brittinger C, Krack P, et al. A randomized trial of deep brain stimulation for Parkinson’s disease. N Engl J Med. 2006;355:896-

908. [Erratum, N Engl J Med. 2006;355:1289.]4. Williams A, Gill S, Varma T, et al. Deep brain stimulation plus best medical therapy versus best medical therapy alone for advanced Parkinson’s

disease (PD SURG trial): a randomised, open-label trial. Lancet Neurol. 2010;9:581-91.5. Follett KA, Weaver FM, Stern M, et al. Pallidal versus subthalamic deep-brain stimulation for Parkinson’s disease. N Engl J Med. 2010;362:2077.

Brief Statement for Medtronic DBS Therapy for Parkinson’s DiseaseMedtronic DBS Therapy for Parkinson’s Disease: Product technical manual must be reviewed prior to use for detailed disclosure.

Indications: 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.Contraindications: Medtronic DBS Therapy is contraindicated for patients who are unable to properly operate the neurostimulator and patients for whom test stimulation is unsuccessful. The following procedures are contraindicated for patients with DBS systems: diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy), which can cause neurostimulation system or tissue damage and can result in severe injury or death; Transcranial Magnetic Stimulation (TMS); and certain MRI procedures using a full body transmit radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil that extends over the chest area if the patient has an implanted Soletra Model 7426 Neurostimulator, Kinetra Model 7428 Neurostimulator, Activa SC Model 37602 Neurostimulator, or Model 64001 or 64002 pocket adaptor. Warnings and Precautions: There is a potential risk of brain tissue damage using stimulation parameter settings of high amplitudes and wide pulse widths and a potential risk to drive tremor using low frequency settings. Extreme care should be used with lead implantation in patients with an increased risk of intracranial hemorrhage. Sources of electromagnetic interference (EMI) may cause device damage or patient injury. 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. The DBS 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. MRI conditions that may cause excessive heating at the lead electrodes which can result in serious injury, including coma, paralysis, or death, or that may cause device damage include: neurostimulator implant location other than pectoral and abdominal regions; unapproved MRI parameters; partial system explants (“abandoned systems”); misidentification of neurostimulator model numbers; and broken conductor wires (in the lead, extension or pocket adaptor). The safety of electroconvulsive therapy (ECT) in patients receiving DBS Therapy has not been established. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Abrupt cessation of stimulation may cause a return of disease symptoms in some cases with intensity greater than was experienced prior to system implant (“rebound effect”). Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging. Depression, suicidal ideations and suicide have been reported in patients receiving Medtronic DBS Therapy for Movement Disorders, although no direct cause-and-effect relationship has been established.Adverse Events: Adverse events related to the therapy, device, or procedure can include intracranial hemorrhage, cerebral infarction, CSF leak, pneumocephalus, seizures, surgical site complications (including pain, infection, dehiscence, erosion, seroma, and hematoma), meningitis, encephalitis, brain abscess, cerebral edema, aseptic cyst formation, device complications (including lead fracture and device migration) that may require revision or explant, extension fibrosis (tightening or bowstringing), new or exacerbation of neurological symptoms (including vision disorders, speech and swallowing disorders, motor coordination and balance disorders, sensory disturbances, cognitive impairment, and sleep disorders), psychiatric and behavioral disorders (including psychosis and abnormal thinking), cough, shocking or jolting sensation, and ineffective therapy. Safety and effectiveness has not been established for: patients with neurological disease other than idiopathic Parkinson’s disease, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients who are pregnant; and patients under 18 years.USA Rx only Rev 0516

Medtronic Inc.710 Medtronic ParkwayMinneapolis, MN 55432 USA Tel. 1-763-505-5000

professional.medtronic.com

KNOW THE RISKS

The risks associated with the implant procedure for Medtronic DBS Therapy may include serious complications such as coma, intracranial hemorrhage, stroke, seizures, cerebral spinal fluid leakage, meningitis, encephalitis, and brain abscess. Some of these may be fatal. Once implanted, device-related infection, skin erosion, and/or system migration may occur. Medtronic DBS Therapy could suddenly cease because of mechanical or electrical problems. Any of these situations may require additional surgery or cause symptoms to return or worsen. Medtronic DBS Therapy may also cause new or worsening neurological, psychiatric, or Parkinson’s-related symptoms. In patients receiving Medtronic DBS Therapy, depression, suicidal ideations, and suicide have been reported.

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