Becker's Spine Review

Becker's Spine Review May/June 2017

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39 Executive Briefing Powered by Illumina 3D ™ 70% BETTER PAIN RELIEF Illumina 3D Provides 70% Better Low Back Pain Relief. Clinical data shows that precise targeting leads to better patient outcomes. Precision Spectra data from multicenter observational study of real-world Precision Spectra clinical outcomes (Hayek, et al., NANS 2014) Precision Plus data from 81 patients at 10 of the 13 US Precision Spectra centers (data pending from remaining centers). Data on file. Presented at the International Neuromodulation Society 12th World Congress, Montreal, Canada, 2015. Indications for Use. Boston Scientific's Spinal Cord Stimulatior Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain. Contraindications. Spinal Cord Stimulatior Systems are not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical risks, or are pregnant. Patients implanted with Spinal Cord Stimulatior Systems with ImageReady MRI Technology are "MR Conditional" only when exposed to the MRI environment under the specific conditions defined in the ImageReady MRI Guidelines for Spinal Cord Stimulatior Systems manuals. Warnings. Patients implanted with Spinal Cord Stimulatior Systems without ImageReady MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to MRI may result in dislodgement of the stimulator or leads, heating of the stimulator, severe damage to the stimulator electronics and an uncomfortable or jolting sensation. As a Spinal Cord Stimulation patient, you should not have diathermy as either a treatment for a medical condition or as part of a surgical procedure. Strong electromagnetic fields, such as power generators or theft detection systems, can potentially turn the stimulator off, or cause uncomfortable jolting stimulation. The system should not be charged while sleeping. Spinal Cord Stimulatior Systems may interfere with the operation of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators. Advise your physician that you have a Spinal Cord Stimulator before going through with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken. Patients should not operate motorized vehicles or potentially dangerous machinery with therapeutic stimulation switched "on." Your doctor may be able to provide additional information on Spinal Cord Stimulatior Systems. For a copy of the Spinal Cord Stimulatior Systems Patient Handbooks, including the indications for use, contraindications, warnings, precautions, and side effects, call 866.360.4747. Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Outside of US Indications for Use: 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 use only in countries with applicable health authority registrations. Material not intended for use in France. Results from clinical studies are not predictive of results in other studies. Results in other studies may vary. All trademarks are the property of their respective owners. NM-279021-AB DEC2016 ©2016 Boston Scientific Corporation or its affiliates. All rights reserved. Printed in the U.S.A. Smallest High Capacity Primary Cell Full-Body MRI Access * More Coverage and Flexibility NEW Illumina 3D Portfolio 70% Better Low Back Pain Relief The Precision Montage ™ MRI SCS System provides safe access to full-body MRI scans only when used with the Avista MRI Leads and exposed to the MRI environment under the specific conditions defined in the ImageReady MRI Full Body Guidelines for Precision Montage ™ MRI Spinal Cord Stimulator System. For more information, go to HCP.ControlYourPain.com

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