Precision TM. Plus. Rechargeable Spinal Cord Stimulation System

Transcription

1 Precision TM Plus Rechargeable Spinal Cord Stimulation System

2 Precisely Target Pain with the Precision Plus SCS System SmoothWave Technology The Power of Multiple Independent Current Control Only the Precision Plus pulse generator has the ability to control the level of power delivered to simultaneously active contacts. * The 16 sources that Precision Plus features, give physicians an unmatched power and flexibility in targeting complex pain syndromes, difficult to treat with conventional systems. Impedance Happens. Precision Adjusts. Impedance varies from contact to contact at time of implant. As patient scarring occurs, impedances change over time. d Precision Plus is the ONLY SCS System that can automatically adjust to impedance changes to maintain therapy over time. d E1 E2 E3 E4 E5 E6 E7 Contact # E8 Implant 2-weeks 3-months 6-months Time of Follow-up Ohms Sources: Oakley J, Prager J, Krames E, Weiner R, Stamatos J, Bradley K. Variability of Contact Impedance Over Time in Spinal Cord Stimulation. Abstracts of the American Society of Stereotactic and Functional Neurosurgery Biennial Meeting, Neuromodulation: Defining the Future, 2004 October 1-3. Cleveland, Ohio. 0 * Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request Tightly Spaced Contacts The percutaneous and surgical leads with tightly spaced contact arrays provide an excellent spatial resolution and allow for shift by 1% of electrical field which enables fine tuning the stimulation. Joystick Control There is no easier way to navigate the electrical field and resulting stimulation to the painful areas than by using a joystick. Moreover, the patient can use the joystick during programming to match paresthesia with painful areas: Patients know their pain best. Bionic Navigator A user-friendly clinician programmer software that makes adjusting parameters of stimulation easy. It enables physicians to assess stimulation combinations at a suprathreshold level allowing for patient s continuous feedback. Thousands of combinations e can be tested in only minutes.

3 Maintain Therapy Over Time with the Precision Plus SCS System EGL Scan Shows Relative Lead Position in Seconds Only the Precision Plus SCS System offers EGL (Electronically Generated Lead) Scan Technology, an exciting proprietary technology that shows the relative position of two implanted leads. In conjunction with the Bionic Navigator software, physicians can use EGL Scan information to assess relative rostrocaudal lead migration. Efficacy Efficient and accurate programming may result in sustained therapy. Maximize practice efficiency by minimizing the need for costly fluoro or x-ray. The Precision Plus SCS System generates and measures electrical stimulation field potentials. These measurements are used to develop a spatial map that indicates the relative position of the contacts to one another. EGL Scan Technology is the only system to date that uses electrical stimulation field potentials to allow clinicians to visualize relative lead position without fluoro or x-ray. Technology Show relative lead position without fluoro in seconds. In about 20 seconds, the results are displayed graphically on your Clinician Programmer. SmoothWave Technology Fluoroscopy Source Current on each contact on Lead 1 Measure Stimulation field potentials on all contacts on Lead Measuring Stimulation Field Potentials Figure A Figure B Figure C Figure D EGL Scan measures Stimulation Field Potentials The fluoroscopic images (Figures A and C) show different offsets between two leads. The SmoothWave Technology (Figures B and D) detected the offsets and displayed graphical representations of the lead offsets. Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request

4 Rechargeable Battery Max PRECISION Plus Voltage/ Capacity 0 Volt Time Precision Plus SCS System Uses the Proprietary Lithium-Ion Zero Volt Battery Technology, a Significant Advance in SCS Therapy. Max Voltage/ Capacity 0 Volt COMPETITOR 1 Degradation Battery Failure Battery Failure and Surgical Intervention 1st Occurrence: 2nd Occurrence: 3rd Occurrence: Overdischarge Time Designed for Reliability Precision Plus can be fully discharged or overdischarged a several times without irrecoverably damaging its battery, providing confidence that Precision Plus will operate for years to come even with noncompliant patients. Max Voltage/ Capacity 0 Volt Degradation or Failure COMPETITOR 2 Stimulation Stops Battery Failure Degradation or Failure Degradation or Failure Potential Battery Failure and Surgical Intervention Overdischarge Designed for Longevity With an estimated battery life up to 25 years under certain stimulation parameters b, Precision Plus potentially will reduce the need of replacements and surgeries for your patient. 30 Days Time Before Battery Failure Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request Designed for Physician Convenience and Patient Comfort Intended to reduce pocket pain, the Precision IPG has atraumatic, rounded edges and a volume of just 22cc. And with an implant depth of up to 2 cm, the Precision IPG offers TWICE the maximum recommended implant depth of similarly sized IPGs *. But patient comfort is about more than a small size, the Precision Plus IPG is designed to offer patient satisfaction with unsurpassed innovative features. Actual Size

5 Patient Lifestyle with the Precision Plus SCS System Cordless Charger: Ultimate Control for Safe Charging The Precision Charger offers constant temperature monitoring to ensure safe and efficient charging. Discreet, lightweight, small and attractive a perfect complement to Precision Plus SCS. Designed for Reliability Built-in thermistor maintains temperature within set range improving charging efficiency and safety. Designed for Simplicity Portable, cordless, lighweight, and small device to facilitate the charging process. One touch operation to activate with automatic shut-off and signal to indicate the IPG charging is complete. Technology Leadership Simplicity of use for the patient, automatic search for alignment with stimulator to ensure efficiency during the charging period. Continuous SCS therapy and temperature monitoring while the patient charges. MOST DISCREET AND MOBILE SYSTEM AVAILABLE Precision Plus Medtronic Restore STJ Eon Cordless Yes No 1 No Tethered to AC No Optional Yes power while charging Patients can be mobile while charging Yes Yes No Options for mobile charging 2: Charger and discreet belt or charger and adhesive 1 Charger connected to antenna via cord. Sources: Medtronic Restore Implant Manual, 37711, STJ Eon Clinician s Manual, F, March Temperature monitoring and cutoff Stimulation can be on while charging Precision Plus Yes, Monitored constantly 1: Charger, transmission coil, and large belt * Source: Medtronic Brochure. Recharging Systems: Restore versus Precision 1: Charger, transmission coil, and large belt COMFORTABLE AND SAFE Medtronic Restore STJ Eon Yes, Monitored every 60 seconds* Yes Yes Yes Not available Base Station for Charger

6 Wireless Remote Control Convenient and user-friendly remote control The Precision Remote Control provides patients with convenient wireless communication. This allows patients to simultaneously see the Remote Control screen, make changes to their stimulation and feel the changes in real-time. Button 1: Program Button Button 2: Area Button Button 3: Up/Activate Down/Save Button 4: Stimulation ON/OFF In seconds, patients can turn stimulation on or off, modify the intensity of their stimulation, or change programs to adjust the areas of stimulation. The Precision Remote Control is easy to learn and easy to use with five large buttons and clear onscreen information. Patients can find the stimulation and program that provide the best comfort. Only Precision Remote Control allows patients to make real-time adjustments over a convenient wireless range of up to 60 cm to date. The Precision Remote Control is easy to use and gives patients real-time control over their own therapy. (a) Arcos, Kramarich, Foster. The Utility of Zero-Volt Battery When Battery Charge is Depleted Abstract of the North American Neuromodulation Society Annual Meeting, 2006 December. (b) Bradley K, Khodavirdi A, Gould B. Precision Rechargeable Spinal Cord Stimulation SCS System: Programming Parameters and Battery Longevity Abstract of the NeuPSIG Meeting / Berlin, 2007 June. (c) Sources for Pulse Width Chart 1. Gould B, Bradley K. Pulse Pulse Widths Programming in Spinal Cord Stimulators Abstracts of the American Academy of Pain Medicine 22nd Annual Meeting, 2006 February Advanced Bionics Precision SCS System Physician Implant Manual. 3. STJ Eon Rechargeable IPG brochure, Medtronic Restore Implant Manual, A (d) Oakley J, Prager J, Krames E, Weiner R, Stamatos J, Bradley K. Variability of Contact Impedance Over Time in Spinal Cord Stimulation. Abstracts of the American Society of Stereotactic and Functional Neurosurgery Biennial Meeting, Neuromodulation: Defining the Future, 2004 October 1-3. Cleveland, Ohio. (e) Varga C, Prager J, Krames E, Oakley J, Bradley K, Grandhe S. A New Efficient Patient-Interactive System for Programming Spinal Cord Stimulators.

7 Powerful and Long Lasting System Total Amplitude (ma) Maximum Pulse Width per Patient vs. Total Amplitude (n = 467 patients) c Boston Scientific Precision STJ Eon MDT Restore Patients Precision Plus can deliver pulse widths up to 1.000µs to date Based on the therapy levels chosen by patients with implanted IPGs, other conventional systems may miss patient optimal coverage. c Pulse Width (µs) Retrospective chart review from 58 clinician programmers (467 patients) c Maintain therapy over time: Longest lasting system to date * Using a single channel stimulation program 98% of Precision TM IPGs would have an expected battery life of greater than 10 years b, and 89% would have greater than 25 years. b Total Amplitude (ma) Maximum Pulse Width per Patient vs. Total Amplitude w/ Projected Battery Life (n = 467 patients) c Boston Scientific Precision capabilities STJ Eon stated capabilities MDT Restore stated 250 Ω MDT Restore stated 700 Ω Patients: > 25 yrs (89 %) Patients: yrs (3 %) Patients: yrs (4 %) Patients: yrs (2 %) Patients: yrs (2 %) * Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request Pulse Width (µs) Projected battery life Retrospective chart review from 58 clinician programmers (467 patients) c

8 Therapeutic Areas of Treatment Deep Brain Stimulation Interventional Radiology Interventional Cardiology Cardiac Rhythm Management Electrophysiology Interventional Bronchoscopy Pain Management Gastroenterology Oncology Women s Health Urology Peripheral Vascular The Company Boston Scientific is one of the world s largest medical device companies dedicated to less-invasive therapies. Our mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures. This is accomplished through the continuing refinement of existing products and procedures and the investigation and development of new technologies which can reduce risk, trauma, cost, procedure time and the need for aftercare. Boston Scientific Revenue: $ 7.6 billion in manufacturing facilities worldwide Employees worldwide: Sales force: more than 40 countries More than Patents issued worldwide Portfolio of more than products All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Boston Scientific Precision : Indications, contraindications and Instructions for use are included in the Instructions for Use contained in the product package. Precision is a registered trademark of Boston Scientific Corporation or its affiliates. NM AA JUL 2012 Printed in Germany by medicalvision Boston Scientific Corporation or its affiliates. All rights reserved. DINNM0019ED