PROVEN NON-INVASIVE TREATMENT FOR RHEUMATOID ARTHRITIS

Similar documents
Corporate Medical Policy

Transcutaneous Electrical Nerve Stimulation Device LUMI-TENS

March 23, Vision Quest Industries, Inc. Mr. Mohammed Ouerghi Director of QA/RA 1390 Decision Street, Suite A Vista, CA 92081

Transcutaneous Electrical Nerve Stimulation Device. Operation Manual Read Before Using

A Genetic Analysis of Rheumatoid Arthritis

Pain Management. Practical Applications in Electrotherapy

Rheumatoid Arthritis

Rheumatoid Arthritis

TAKING CARE OF YOUR RHEUMATOID ARTHRITIS

TENS, Electroacupuncture and Ice Massage: Comparison of Treatment for Osteoarthritis of the Knee

Once the immune system is triggered, cells migrate from the blood into the joints and produce substances that cause inflammation.

Rheumatoid Arthritis. Outline. Treatment Goal 4/10/2013. Clinical evaluation New treatment options Future research Discussion

Understanding Rheumatoid Arthritis

What is Rheumatoid Arthritis?

Information on Rheumatoid Arthritis

Biologic Treatments for Rheumatoid Arthritis

Rheumatoid Arthritis

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)

ABOUT RHEUMATOID ARTHRITIS

Spinal Cord Stimulation (SCS) Therapy: Fact Sheet

X-Plain Rheumatoid Arthritis Reference Summary

Test Request Tip Sheet

Shared care protocol for the management of patients with Rheumatoid Arthritis treated with disease modifying antirheumatic drugs (DMARDs)

How To Choose A Biologic Drug

Ultima 20 User s manual

The Most Common Autoimmune Disease: Rheumatoid Arthritis. Bonita S. Libman, M.D.

Psoriatic Arthritis

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

Medicines for Psoriatic Arthritis. A Review of the Research for Adults

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

Facts About Aging and Bone Health

RHEUMATOID ARTHRITIS: PRIMARILY AN AUTOIMMUNE DISEASE JOHNATHON DUFTON, MD

world-class orthopedic care right in your own backyard.

Rheumatoid Arthritis Information

Osteoporosis and Arthritis: Two Common but Different Conditions

Rheumatology. Rheumatoid Arthritis

Medication Policy Manual. Topic: Aubagio, teriflunomide Date of Origin: November 9, 2012

Arthritis

Rheumatoid Arthritis. Nicole Klett,, M.D.

Arthritis of the Shoulder

Disclosures. Consultant and Speaker for Biogen Idec, TEVA Neuroscience, EMD Serrono, Mallinckrodt, Novartis, Genzyme, Accorda Therapeutics

Biomet SpinalPak Non-Invasive Spine Fusion Stimulator System

Therall. Arthritis. Living with. A guide to understanding and managing Arthritis

Disease Therapy Management (DTM) Enhances Rheumatoid Arthritis Treatment

Outline. Personal profile & research interests. Rheumatology research in Ireland. Current standing. Future plans

Rheumatoid Arthritis. Disease RA Final.indd :23

TENS and Electrodes Guide

(Intro to Arthritis with a. Arthritis) Manager of Education & Services for the Vancouver Island Region of The Arthritis Society

The Total Ankle Replacement

Infl ectra for rheumatoid arthritis

DIVISION OF RHEUMATOLOGY DEPARTMENT OF MEDICINE UNIVERSITY OF WESTERN ONTARIO POSTGRADUATE EDUCTION ORTHOPAEDIC OFF-SERVICE GOALS & OBJECTIVES

SYNOPSIS. 2-Year (0.5 DB OL) Addendum to Clinical Study Report

Methotrexate (Rheumatoid Arthritis) - Forecast and Market Analysis to 2023

Do I need a physician referral? Yes, we see patients on referral from a health care provider.

GLUCOSAMINE, CHONDROITIN, AND MSM

BEDFORDSHIRE AND LUTON JOINT PRESCRIBING COMMITTEE (JPC)

ARTHRITIS and ACUPUNCTURE

Back & Neck Pain Survival Guide

Treatment of Severe Rheumatoid Arthritis

Objectives: Immunity Gone Wrong: Autoimmune Diseases in Dental Hygiene Practice

subcutaneous initially every 4 weeks then every 12 weeks Coverage Criteria: Express Scripts, Inc. monograph dated 02/24/2010

Thymus Cancer. This reference summary will help you better understand what thymus cancer is and what treatment options are available.

Hand Injuries and Disorders

Cervical Spondylosis (Arthritis of the Neck)

ARTHRITIS INTRODUCTION

Temple Physical Therapy

Arthritis in Children: Juvenile Rheumatoid Arthritis By Kerry V. Cooke

Immune modulation in rheumatology. Geoff McColl University of Melbourne/Australian Rheumatology Association

INITIATING ORAL AUBAGIO (teriflunomide) THERAPY


Dr Sarah Levy Consultant Rheumatology Croydon University Hospital

MARKET ANALYSIS of ActiPatch Therapy Try & Tell Surveys

.org. Arthritis of the Hand. Description

Rheumatoid Arthritis monitoring of DMARDs

arthritis.org Rheumatoid Arthritis Understanding Symptoms, Diagnosis and Treatments

Informed Patient Tutorial Copyright 2012 by the American Academy of Orthopaedic Surgeons

Not All Clinical Trials Are Created Equal Understanding the Different Phases

Rheumatoid Arthritis: Symptoms, Causes, and Treatments of Rheumatoid Foot and Ankle

Prescribing Framework for Donepezil in the Treatment and Management of Dementia

Herniated Cervical Disc

Rheumatoid Arthritis

W40 Total prosthetic replacement of knee joint using cement

ELECTROMYOGRAPHY (EMG), NEEDLE, NERVE CONDUCTION STUDIES (NCS) AND QUANTITATIVE SENSORY TESTING (QST)

Speaking Plainly. Biologic treatment options for rheumatoid arthritis

Ask Your Doctor if There May Be a SMARTER CHOICE

Patient Input Information Clinical Trials Outcomes Common Drug Review

Alternative Treatments for Arthritis

Managing canine osteoarthritis: What has proven benefits?

Arthritis: An Overview. Michael McKee, MD, MPH February 23, 2012

Integra. MCP Joint Replacement PATIENT INFORMATION

FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C

Elbow Injuries and Disorders

Physician Labeling. ( Clinical Application of the Duolith SD1 will be added to Operating Manuals upon PMA Approval.)

Transcription:

PROVEN NON-INVASIVE TREATMENT FOR RHEUMATOID ARTHRITIS

BIONICARE HAND SYSTEM Non-drug, non-invasive Adjunctive therapy For patients symptomatic despite current therapy For patients intolerant to drug therapy For patients wanting an alternative Clinically proven to reduce pain and stiffness

BIO-2000 Touch-screen interface Slim and compact Web-based reporting capabilities GENERATOR DOCK Wireless system Universal Low-profile Generator easily snaps into place GLOVE BIO-2000 CONDUCTIVE SYSTEM Easy to apply Comfortable Targeted stimulation to each hand and wrist joint* Conductors facilitate signal transmission *Proven in finite element analysis GENERATOR DOCK CONDUCTORS

PROVEN NON-INVASIVE TREATMENT FOR RA A multi-center, prospective, double-blind, randomized, placebo-controlled clinical study to evaluate the safety and efficacy of the BioniCare Hand Device in the management of RA hand pain. 89 patients 6 centers Patients treated with BioniCare 8 ( ± 2) hours per day for 4 weeks Patients maintained on stable doses of NSAIDs, DMARDs and/or analgesics throughout the study PATIENTS EVALUATION OF PAIN AND SYMPTOMS PATIENT EVALUATION OF FUNCTION PHYSICIAN S GLOBAL EVALUATION Improvement from the Baseline Improvement from the Baseline Improvement from the Baseline IMPROVEMENT (VAS) 2.0 0.5 0.9 0.5 1.6 0.8 1.6 1.9 1.1 IMPROVEMENT (VAS) 2.0 0.5 0.9 0.6 1.1 1.8 IMPROVEMENT (VAS) 2.5 2.0 0.5 0.9 0.7 0.9 1.8 1.1 2.1 0.0 Week 1 Week 2 Week 3 Week4 0.0 Week 1 Week 2 Week 3 Week 4 0.0 Week 1 Week 2 Week 3 Week 4 Active (N=45) Placebo (N=44) Active (N=45) Placebo (N=44) Active (N=45) Placebo (N=44) 73% GREATER IMPROVEMENT in patient evaluation of pain and symptoms 80% GREATER IMPROVEMENT in patient evaluation of function 40% IMPROVEMENT in disease activity

BIONICARE SCIENCE Rheumatoid arthritis is characterized by the degradation of the joint by inflammatory cytokines. Scientific research supports the hypothesis that electrical signals can increase aggrecan and Type II collagen synthesis and decrease inflammatory cytokines involved in the inflammation of rheumatoid arthritis. 1,2 The BioniCare signal has been proven to reduce pain and medications, increase function, defer surgery and improve the overall condition of synovial joints. The BioniCare Hand System signal has been proven to decrease the pain and symptoms of rheumatoid arthritis of the hand. 3 1 Brighton CT, Wang W, Clark CC. The effect of electrical fields on gene and protein expression in human osteoarthritis cartilage explants. J Bone Joint Surg Am. 2008 Apr;90(4):833-48. 2 Wang W, Wang W, Zhang G, Clark CC, Brighton CT. Up-regulation of chondrocyte matrix genes and products by electrical fields. Clin Orthop Relat Res. 2004 Oct;(427 Suppl):S163-73. 3 Zizic TM, Hoffman KC, He YD, Caldwell JR, Deal C, Holt PA, Hungerford DS, Jacobs MA, Klaussen LW, Krackow K, O Dell JR, Smith C. The treatment of rheumatoid arthritis of the hand with pulsed electrical fields. Electricity and Magnetism in Biology and Medicine. New York: Kluwer Academic/Plenum 1999, 939-42.

TRACK COMPLIANCE AND MEASURE PROGRESS! BIO-2000 patient usage data and personalized outcome responses are uploaded and tracked at www.bionicare.com.* Patients can print progress report that can be shared during office visits Review usage and efficacy to assist in treatment planning Provides resources for your patients: track progress news stories links to arthritis information tips for healthy living information about the BIO-2000 device *Patient access requires software installation and registration Participation in the BioniCare.com web site is voluntary. The device provides complete treatment without any connection to the web site.

INDICATION The BioniCare Hand System is indicated for use as an adjunctive therapy in reducing the level of pain and stiffness associated with pain from rheumatoid arthritis of the hand. CONTRAINDICATIONS Do not use the BioniCare Hand System for any electrode placement that applies current to the carotid sinus (neck) region. Do not use the BioniCare Hand System for any electrode placement that causes current to flow transcerebrally (through the head). Patients with demand type cardiac pacemakers should consult with their physician prior to use of this system. Do not use the BioniCare Hand System whenever pain syndromes are undiagnosed, until etiology is established. WARNINGS The BioniCare Hand System must be used only as prescribed and applied only to the hand. The safety of the BioniCare Hand System for use during pregnancy has not been established. The BioniCare Hand System is not effective for pain of central origin (including headache). Use only under the continued supervision of a physician. Keep out of reach of children. Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when the BioniCare Hand Device is in use. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or any other practitioner licensed by the law of the State in which he practices. WARNINGS: If you experience pain, swelling, sensation changes, or unusual reactions while using this product, contact VQ OrthoCare s Patient Care department at 800.444.1456 or consult a physician. www.bionicare.com PRECAUTIONS Isolated cases of skin irritation may occur at the site of conductors or conductive glove placement following long-term application. Effectiveness is highly dependent upon patient selection by a physician qualified in the management of arthritis. 18011 Mitchell South Irvine,CA 92614 800.266.6969 www.vqorthocare.com 2012 VisionQuest Industries, Inc. VQO511647REVB