Activa RC and Activa PC

Transcription

1 Activa RC and Activa PC neurostimulators for deep brain stimulation

2 From the company with the most experience in DBS The Activa Family Innovative programming platform More choices for patients With the confidence and support that comes from the industry leader The first rechargeable and the most advanced nonrechargeable neurostimulators

3 The Next Generation in DBS Innovation M o v i n g D B S T h e r a p y F o r w a r d Innovation is at the core of the Activa RC and Activa PC family of systems. From the first rechargeable DBS device, to sophisticated programming tools and a fully-featured patient programmer, you have more ways to control therapy delivery and tailor information provided to the patient. When you choose the Activa RC rechargeable DBS device for your patients, they will receive the thinnest and lightest DBS device available. Both systems provide clinicians with an array of programming options designed to achieve optimal therapy benefits for patients. With both devices, you ll have unprecedented ability to control the stimulation field with innovative interleaved pulses and patientspecific therapy groups. The Activa RC and Activa PC family of systems utilizes internal memory to store information. The patient s medical history, therapeutic window parameters, and valuable information about actual therapy usage can be stored within the device. The sorting capabilities of the device help you choose settings that will allow you to program a positive therapeutic response while maximizing power-usage efficiency.

4 I N N O V A T I O N Activa RC and Activa PC provide unrivaled nextgeneration technology, increasing the breadth of options available to patients and clinicians. Guided Programming Enables a step-by-step, systematic approach to programming Advanced Programming Assign multiple stimulation programs per lead Create up to four therapy groups, designed to reach optimized settings sooner DBS Patient Programmer Work more closely with your patient to individualize delivery of the therapy Stretch-Coil extension Accommodates the natural movement of the patient s head, neck, and shoulders More Tools to Meet Clinical Needs Predictable longevity for informed decisions The information you need to: Program settings that are both therapeutic and power efficient Plan effectively throughout the life cycle of the device Individualized Patient Management Fully-featured patient programmer: Provides more therapy information than ever before Enables customization of the information to meet individual patient needs The device stores the patient s history and settings so information can travel with the patient.

5 Artistic representation of the Medtronic DBS visualization software. Visual effects simulated. Taking DBS Programming to the Next Level R e f i n e t h e r a p y d e l i v e r y Interleaving provides the option for two programs to be assigned to each lead. Each program can be delivered to different electrodes, and can have a different combination of pulse width and amplitude. The pulses are delivered in an alternating interleaved fashion, which allows for finer control of the stimulation field. The ability to define up to four therapy groups may allow optimized therapy settings to be reached sooner.

6 C H O I C E Because Each Patient Is Different Medtronic provides you with a full range of device and programming options, so you can individualize patient care. Clinicians can regulate therapy delivery through either voltage mode or current mode of operation. Activa RC is the first rechargeable device, and Activa PC offers advanced features in a maintenancefree device. Both infrequent and advanced users can select from multiple programming options to meet their needs. Physicians can customize limits of therapy adjustability for each patient. More choice for patients Patients can check battery and programmer battery status, adjust stimulation parameters, and change active therapy groups according to the limits you set. Programmer shown actual size.

7 We Provide More Choices Device Options Programming Options Activa RC Device Smallest, thinnest DBS device available Longest interval between device replacements Ideal patients Symptoms respond best to higher parameters Willing and able to interact with their system Activa PC Device The same innovative programming and therapeutic capabilities as Activa RC Smallest dual-channel nonrechargeable device Ideal patients Best suited for a maintenance-free device Guided Programming Systematically steps you through programming sessions Menu-driven prompts Benefits and side effects associated with certain parameters are stored in the neurostimulator, designed to reduce reliance on handwritten notes Advanced Programming Voltage mode AND current mode Groups provide patients with the option to choose from among up to four groups of therapy settings Multiple programs per lead offer finer control Patients can make adjustments to their therapy using the icon-driven patient programmer Information Management Options Extensive Data Management Capabilities Transform programming from a pencil and paper exercise to a convenient device-based medical record Because the data travels with the patient, it s always there when you need it

8 C O N F I D E N C E Building on More than Two Decades of Experience When French neurosurgeon Professor Alim Benabid and his team implanted the first Medtronic DBS System in 1987, they were pushing the frontiers of medicine in order to develop better therapy for patients with disabling tremor. Since that first implant, more than 55,000 people worldwide 1 have received Medtronic DBS Therapy. Designed with insight gained from the most experience in the industry, we developed an entirely new family of devices and tools the Activa RC and Activa PC systems. This comprehensive family of products brings you the innovation and choice you need so you can deliver DBS Therapy with confidence. more than 55,000 Medtronic DBS implants4

9 Collaborating to Advance DBS Therapy Prof. Alim Benabid, MD, a neurosurgeon, and his team in Grenoble, France implant a Medtronic Itrel device to control disabling tremor and begin the first systemic study of thalamic stimulation Start of Medtronicsponsored European multicenter clinical study of thalamic stimulation for tremor Thalamic brain stimulation therapy for essential tremor and Parkinson s disease available in Europe, Canada, and Australia US Food and Drug Administration (FDA) approval for essential tremor and tremor in Parkinson s disease Efficacy and safety information on DBS Therapy published in the first of a series of landmark articles that appeared in the New England Journal of Medicine FDA approval for advanced Parkinson s disease motor symptoms Long-term benefits and safety of Medtronic DBS Therapy for Parkinson s disease demonstrated 3 Medtronic DBS Therapy and medication are proven to be more effective than the best medical therapy alone 55,000 Medtronic DBS implants to date 1 Activa family introduces advanced programming and first rechargeable device for DBS

10 Proven Clinician Support You can count on getting answers when you need them from DBS technical experts with the most knowledge and experience. In addition, comprehensive education and training opportunities are available for you and your staff, whether you are just getting started or have many years of experience. Curriculum for Life Customized courses for both neurosurgeons and neurologists on the following topics: Online Fundamentals of Medtronic DBS Therapy Course Basic Course: Focus on Patient Selection and Programming Intermediate Course: Focus on Referring and Practice Management for Medtronic DBS Therapy Advanced Course: Focus on Innovative Theory and Technique for Medtronic DBS Therapy Surgeons Course: Focus on DBS Mini-Frame Technology for Medtronic DBS Therapy

11 Activa RC Activa PC Height 54 mm 65mm Length 54 mm 49 mm Case thickness 9 mm 15 mm Connector thickness 11 mm 15 mm Weight 45 g 66 g Volume 22 cc 39 cc Battery type Lithium ion Silver vanadium oxide Rechargeable Primary cell Battery longevity 9 years 2-5 years (Dependent on stimulation parameters and use) Specifications Common Parameters Amplitude Rate V (voltage mode) ma (current mode) Hz (voltage mode) 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/stop Off, On Ramp duration 1, 2, 4, 8 seconds Cycling Off, On Connector type Octapolar, in-line 2.8-mm spacing Electrode configuration Case External shield Up to 4 electrodes per lead defined as anode, cathode, or Off Defined as anode or OFF Titanium DEVICES SHOWN ACTUAL SIZE

12 References 1. Medtronic. Data on file. 2. The Deep-Brain Stimulation for Parkinson s 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: Krack P, Batir A, Van Blercom N, et al. Five-year follow-up of bilateral stimulation of the subthalamic nucleus in advanced Parkinson s disease. N Engl J Med. 2003;349: Brief Summary Disclosure for Parkinson s and Tremor Control Therapy Activa Parkinson s Control Therapy and Tremor Control Therapy: Product technical manual must be reviewed prior to use for detailed disclosure. 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. The safety or effectiveness of this therapy has not been established for bilateral stimulation. 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 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. 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). 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. USA Rx only Rev United States of America Medtronic Neuromodulation 710 Medtronic Parkway Minneapolis, MN USA Tel Toll-free Europe Medtronic International Trading Sàrl Route du Molliau 31 Case Postale CH-1131 Tolochenaz Switzerland Tel Asia-Pacific Medtronic International, Ltd. Suite /F Manulife Plaza The Lee Gardens, 33 Hysan Avenue Causeway Bay Hong Kong Tel Australia Medtronic Australasia Pty. Ltd. 97 Waterloo Road North Ryde NSW 2113 Australia Tel Canada Medtronic of Canada Ltd Kitimat Road Mississauga, Ontario L5N 1W3 Canada Tel UC EN NI8950 Medtronic, Inc All Rights Reserved. Printed in USA.