Similar documents
Corporate Medical Policy

Special Control Guidance for Premarket Notifications for Totally Implanted Spinal Cord Stimulators for Pain Relief

INSERTABLE CARDIAC MONITORING SYSTEM. UNLOCK the ANSWER. Your heart and long-term monitoring

MRI Case Study MRI Cervical Spine

Precision Spinal Cord Stimulator System Clinician Manual

Spinal Cord Stimulation (SCS) Therapy: Fact Sheet

NeuroPace. RNS System Patient Manual

User Manual Table of Contents. Instructions for Using the LaserTouchOne Charging the Unit... 5 Holding the Device... 5 Treatment Steps...

Boston Scientific Spinal Cord Stimulation (SCS) Systems

CareLink Network. Clinic Setup Guide WORKFLOWS. FAQs

RNS System Clinical Summary

ImageReady MRI Full Body Guidelines for Precision Montage MRI Spinal Cord Stimulator System

NeuroPace RNS System Patient Manual

NeuroPace RNS System Patient Manual

Vagus Nerve Stimulation (VNS)

EXHIBIT C BOSTON SCIENTIFIC PRODUCTS AVAILABLE FOR NIH BRAIN INITIATIVE Page 1 of 9

Pain Management. Practical Applications in Electrotherapy

Laser Treatment Policy

InterStim Therapy For Bowel Control Problems Patient Guide

What Are Arrhythmias?

RNS System User Manual

ENGLISH...3 DEUTSCH...13 FRANÇAIS...23 ESPAÑOL...33 ITALIANO...43 PORTUGUÊS...53

Contractor Number Oversight Region Region IV

Spinal cord stimulation

1.5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System

Zapping the Pain Away: Technology and Pain Management Jennifer French, MBA Executive Director Neurotech Network

The patient was a 48-year-old

Breast Implants: Local Complications and Adverse Outcomes

Spinal Cord Stimulation

A Patient s Guide to Artificial Cervical Disc Replacement

Managing Chronic Pain with Spinal Cord Stimulation Therapy

Epilepsy Patient s Manual

A Patient s Guide to Minimally Invasive Abdominal Aortic Aneurysm Repair

REVEAL LINQ LNQ11. Insertable Cardiac Monitor MRI procedural information. MRI Technical Manual

Christopher M. Wright, MD, MBA Pioneer Cardiovascular Consultants Tempe, Arizona

Deep Brain Stimulation for Essential Tremor and Parkinson s Disease (NCD )

NeuroPace Remote Monitor Manual

Neurostimulation: Orthopaedic Institute of Ohio 801 Medical Drive Lima, Ohio

Suffering from varicose veins? Patient Information. ELVeS Radial Minimally invasive laser therapy of venous insufficiency

Contraindications & Precautions

MEDICAL CONTESTED CASE HEARING NO M DECISION AND ORDER

INFUSE Bone Graft. Patient Information Brochure

Transcutaneous Electrical Nerve Stimulation Device LUMI-TENS

SPINE AND NECK SURGERY: MAKING A DECISION THAT S RIGHT FOR YOU

(English) NEXUS SPINE SPACER SYSTEM

Miscellaneous Services

Introduction. Planned surgical procedures

Medical Procedures and EMI Precautions

Local Coverage Determination (LCD): Spinal Cord Stimulation (Dorsal Column Stimulation) (L34705)

LOSS OF BLADDER CONTROL IS TREATABLE TAKE CONTROL AND RESTORE YOUR LIFESTYLE

Pacemaker Counter and Histogram Operation and Interpretation. Percentage of total count. Figure 2. Detailed ALTRUA Paced and Sensed Event Counters

Quick Facts about Breast Augmentation with IDEAL IMPLANT Saline-filled Breast Implants

User Manual Encore Medical, L.P.

INFORMED-CONSENT BREAST AUGMENTATION

INFUSE Bone Graft (rhbmp-2/acs)

Page 1 of 7 Patient s Initials version

It is important that you read this information carefully and completely.

NeuroStar TMS Therapy Patient Guide for Treating Depression

Electrodiagnostic Testing

Marc A. Cohen, MD, FAAOS, FACS Diplomate American Board of Spinal Surgery Fellow American College of Spinal Surgery

Biomet SpinalPak Non-Invasive Spine Fusion Stimulator System

Vagus Nerve Stimulator (VNS)

LOW BACK PAIN: SHOULD I HAVE AN MRI?

PROVEN NON-INVASIVE TREATMENT FOR RHEUMATOID ARTHRITIS

TABLE OF CONTENTS. Surgical Technique 2. Indications 4. Product Information Patient Positioning and Approach 2

Options for Cervical Disc Degeneration A Guide to the Fusion Arm of the M6 -C Artificial Disc Study

There are only four actions that a patient can take to attempt to correct a monitor error:

FREEDOM INGUINAL Hernia Repair System TECHNIQUE GUIDE

Electroconvulsive Therapy - ECT

Refer to Coaptite Injectable Implant Instructions for Use provided with product for complete instructions for use.

Chronic Low Back Pain

MRI SureScan Pacing System

Reimbursement Assistance: For Reveal ICM products, please call the Medtronic CRHF Coding Hotline at 1 (866)

HOW TO USE THE LIFEPAK 1000 DEFIBRILLATOR 3

Herniated Cervical Disc

What Can I Do about Atrial Fibrillation (AF)?

DIFFERENTIAL DIAGNOSIS OF LOW BACK PAIN. Arnold J. Weil, M.D., M.B.A. Non-Surgical Orthopaedics, P.C. Atlanta, GA

NeuroPace Remote Monitor Manual

Herniated Disk. This reference summary explains herniated disks. It discusses symptoms and causes of the condition, as well as treatment options.

Scout Vessel Guard. A cover for vessels during anterior lumbar spine surgery.

VNS Therapy for Epilepsy

Y O U R S U R G E O N S. choice of. implants F O R Y O U R S U R G E R Y

TOM J. POUSTI, MD, F.A.C.S. PLASTIC AND RECONSTRUCTION SURGERY

Worldwide Experience with S-ICD: Early results from the EFFORTLESS Registry

Transmittal 55 Date: MAY 5, SUBJECT: Changes Conforming to CR3648 for Therapy Services

Transcutaneous Electrical Nerve Stimulation Device. Operation Manual Read Before Using

Herniated Lumbar Disc

Normal bladder function requires a coordinated effort between the brain, spinal cord, and the bladder.

Provant Therapy System

A PATIENT S GUIDE TO ABLATION THERAPY

Your pacemaker system information

CLINICIAN MANUAL. LATITUDE NXT Patient Management System

SUUNTO COMFORT BELT Heart Rate Transmitter Belts USER GUIDE

Numerical Modelling of E-M Occupational Exposures associated with MRI

1st Edition Quick reference guide for the management of acute whiplash. associated disorders

NEUROMODULATION THERAPY ACCESS COALITION POSITION STATEMENT ON SPINAL CORD NEUROSTIMULATION

How To Manage A Catastrophic Injury

RF safety at base station sites

Transcription:

Epimed Would Like To Congratulate The 20th Annual Budapest Conference The New Shape of Pain Relief SmalleST. ThiNNeST. CoNTouRed design. Precision Novi is the world s smallest, thinnest 16 contact primary cell SCS device with a unique contoured shape. We d like to congratulate the Budapest Conference along with the WIP for 20 years of service and contributions to pain management. Epimed is honored to continue it s support of the WIP and pain physicians around the world. 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 labeling supplied with each device. Information for the use only in countries with applicable health authority product registrations Boston Scientific Precision Novi : Indications, contraindications and Instructions for use are included in the Instructions for Use contained in the product package. Precision Novi is a registered trademark of Boston Scientific Corporation or its affiliates. Images courtesy of Boston Scientific Corporation. All cited trademarks are the property of their respective owners. All Statements have been validated as of February 2015. Reference: Precision Novi Directions for Use (2015). Medtronic Prime Advanced Implant Manual (2006) St. Jude Eon C Sell Sheet (2009) NM-300006-AA_FEB2015 2015 Boston Scientific Corporation or its affiliates. All rights reserved. LT-169 Rev. 0

PERSONALISE PAIN MANAGEMENT ALL THE TIME. ANYTIME. AdaptiveStim HD Responds automatically by adjusting stimulation to your patient s preferred setting at any density. Learn more at professional.medtronic.com Note: Medtronic does not have clinical data on the efficacy of its devices when set at High Density Programming. www.medtronic.eu NEUROSTIMULATION SYSTEMS FOR PAIN THERAPY Brief Summary: Product manuals must be reviewed prior to use for detailed disclosure. Indication Neurostimulation for Spinal Cord Stimulation (SCS) Medtronic SCS neurostimulation system is indicated for SCS as an aid in the management of chronic, intractable pain of the trunk and/or limbs, peripheral vascular disease, or intractable angina pectoris. Neurostimulation for Peripheral Nerve Stimulation (PNS) using percutaneous leads - A Medtronic PNS neurostimulation system is indicated for PNS as an aid in the management of chronic, intractable pain of the posterior trunk. Neurostimulation for Peripheral Nerve Stimulation (PNS) using surgical leads A Medtronic PNS neurostimulation system is indicated for PNS as an aid in the management of chronic, intractable pain of the trunk and/or limbs. Contraindications Diathermy Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the locations of the implanted electrodes, resulting in severe injury or death. Warnings Sources of strong electromagnetic interference (eg, defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact with the neurostimulation system, resulting in serious patient injury or death. These and other sources of EMI can also result in system damage, operational changes to the neurostimulator or unexpected changes in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device (eg, pacemaker, defibrillator) may damage a neurostimulator, and the electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device. Patients treated for intractable angina pectoris should be educated on the signs and symptoms of myocardial infarction and should seek medical attention immediately if signs and symptoms develop. Precautions The safety and effectiveness of this therapy has not been established for pediatric use (patients under the age of 18), pregnancy, unborn fetus, or delivery. Patients should be detoxified from narcotics prior to lead placement. Clinicians and patients should follow programming guidelines and precautions provided in product manuals. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other activities may cause shocking or jolting. Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging. Adverse Events Adverse events may include: undesirable change in stimulation described by some patients as uncomfortable, jolting or shocking; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, and surgical risks. UC201503922EE 2015 Medtronic, Inc. All rights reserved. Printed in Europe. Not for distribution in France. When HAPPINESS leaves her speechless, the results say it all. 94% more patients achieved a back pain score of 2.5 with HF10 therapy vs. traditional SCS at 12 months. Source: Kapural, Leonardo et al. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain. Anesthesiology 123, no. 4 (2015). 2015106 Rev. A

wireless pain relief freedom Spinal Cord Stimulators INNOVATION. NOT IMITATION. Innovation means nothing without results. So while others may try to replicate the St. Jude Medical Burst waveform, ours is being supported by a growing body of evidence* and rigorous product development. At St. Jude Medical, we don t just advertise our innovation we prove it. The Most Versatile System: + + + MR 4 or 8 Electrodes, Polarity Select Low-Frequency, Adaptive Power High-Frequency, to 10 khz Spike Waveform Programming DRG Placements IPG-Free Percutaneous Procedure 1.5T & 3T MRI Full Body Conditional BURST STIMULATION ACCEPT. NO SUBSTITUTES. *Learn more at SJM.com/Burst Full Body MRI-Use under specific conditions for both 1.5T & 3T MRI scans. Refer to approved labeling for conditions. Indications for Use. The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom System is contraindicated for patients who: are unable to operate the Freedom System, are poor surgical risks, are pregnant, have an occupational exposure to high non-ionizaing radiation, are implanted with cardiac system, or diathermy. Refer to the Instructions for Use provided with the Freedom SCS System or Stimwave.com for potential adverse effects, warnings, and precautions prior to using this product. Rx Only. Wireless Pain Relief is a registered trademark of Stimwave. 2015 Stimwave Technologies Incorporated. Unless otherwise noted, indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. 2015 St. Jude Medical, Inc. All Rights Reserved. SJM-CPG-0515-0012(1) Item approved for global use.

Big things come in small packages. With its all-in-one design, Ziehm Solo is one of the most compact and versatile C-arms for crowded treatment scenarios. Equipped with state-of-the-art imaging technology, this C-arm delivers great performance for orthopedics, traumatology, pain management and other applications. Made in Germany. www.ziehm.com