Illumina 3D Portfolio
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1 illumina 3D Portfolio Only the Illumina 3D Portfolio can customize therapy by delivering multiple waveforms to a precise neural target. Illumina 3D Portfolio Right Target. Right Waveform. Customized Therapy. RIGHT Target: Illumina 3D RIGHT Waveform: MultiWave Customized Therapy Smallest High Capacity Primary Cell Full-Body MRI Access * * 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 MRI Guidelines for Precision Montage Spinal Cord Stimulator System. The Precision Spectra SCS System with ImageReady MRI Technology is MR-Conditional only when exposed to the MRI environment under the specific conditions defined in the ImageReady MRI Guidelines for Precision Spectra Spinal Cord Stimulator System. US Indications for Use: The Boston Scientific Neuromodulation Spinal Cord Stimulator (SCS) 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, warnings, precautions, side effects. The SCS Systems are contraindicated for patients who: are unable to operate the SCS System, have failed trial stimulation by failing to receive effective pain relief, are poor surgical risks, or are pregnant. Refer to the Instructions for Use provided with the SCS System or ControlYourPain.com for potential adverse effects, warnings, and precautions prior to using this product. Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Outside of US Indications for Use: For further information refer to the product labeling and Instructions for Use provided with each product which includes indications, contraindications, warnings and precautions. Not for distribution 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. More information for health care professionals can be found at HCP.ControlYourPain.com Rye Canyon Loop Valencia, CA USA Copyright 2016 by Boston Scientific Corporation or its affiliates. All rights reserved. NM AA_APR2016 *under specified conditions More Coverage and Flexibility
2 Pain is Dynamic, and Every Patient is Unique Your SCS System should be too. At Boston Scientific, we believe a successful outcome is dependent on a system s ability to customize therapy to fit each unique patient and pain pattern. This is why we developed the Illumina 3D Portfolio, built on a basic formula. right target: illumina 3D The equation for a successful outcome starts with identifying the right neural target. The Illumina 3D Neural Targeting Algorithm is the only algorithm based on a 3D anatomical model of the spinal cord, designed to enable quick and precise pain targeting. Step 1 Input Leads into the 3D Environment Customized Therapy FluoroSync Interface: Inputs the 3-dimensional lead location into the Illumina 3D Programming Algorithm + Find the Right Target Apply the Right Waveform Illumina 3D Programming Finding the Right Neural Target Step 2 Automatic Programming Drag-and-drop the leads into the FluoroSync Interface. Select the central point of stimulation with point-and-click simplicity. The Illumina 3D Algorithm automatically calculates the optimal programming configuration to target the selected point. Illumina 3D is Designed to Enable More Precise Targeting. This has led to Better Patient Outcomes.
3 Better Outcomes with illumina 3D 70% Illumina 3D Technology has proven to provide 70% better low back pain relief than our previous generation system. Sustained Pain Relief with Illumina 3D NRS In the LUMINA multi-center observational study of 213 consecutive Precision Spectra patients across 13 sites, highly significant pain relief was maintained out to 24 months OVERALL PAIN OUTCOMES 7.17 Δ = 4.23 (p<0.0001) NRS LOW back pain outcomes 8.60 Δ = 5.62 (p<0.0001) the Illumina 3D Portfolio is designed to customize therapy by delivering multiple waveforms to a precise neural target Baseline (N = 213) 24 Mos (N = 169) 0 Baseline (N = 49) 24 Mos (N = 38) All Patients Severe Patients (Baseline NRS 8) This pain relief, Powered by Illumina 3D, is now available in a complete portfolio of devices to treat the varying needs of your unique patients.
4 Right Waveform: multiwave Once you have found the right target, the next step to a successful outcome is to apply the right waveform. MultiWave Technology allows you to customize therapy for each patient by offering a broad spectrum of waveform options. MultiWave Technology 72% In Registry of 800 SCS Patients, 72% Used Multiple Waveforms to Customize Pain Relief Prism 3D Targeting Technology Engineered to recruit more and deeper nerve fibers Among this group of patients, there was a high degree of waveform customization. Only MultiWave Technology gives patients this level of flexibility in treating their pain. Burst 3D Stimulation Customizable burst waveforms, 2-7 pulses, up to 1000 μs pulse width Of the patients using Multiple Waveforms: 62%: Standard Rate 49%: HR 3D HR 3D + Prism 39%: Prism 3D 36%: Burst 3D 14% HR 3D + Burst 3D 6% 3+ Waveforms 9% HR 3D + Standard Rate 29% N=576 Burst 3D + Prism 3D 13% Burst 3D + Standard Rate 17% HR 3D Stimulation Kilohertz stimulation between 1,000 and 1,200 Hz Prism 3D + Standard Rate 12%
5 Selecting the right device Spectra: More Coverage and flexiblity Ultimate Trialling System All Devices in the Illumina 3D Portfolio begin with the ultimate trialing system A Precision Spectra Trial. 32 contacts spanning 3 vertebral levels gives you the coverage you need to quickly and easily identify the Right Target area for permanent lead placement. During the trial the patient will also be able to experience a variety of waveform options giving you the flexibility to choose the Right Waveform and device that best suits their needs. More Coverage 32 contacts and 32 dedicated power sources Seamless coverage of up to 3 vertebral bodies with Infinion leads or the CoverEdge Paddle More Flexibility four ports and an unrivaled lead portfolio offer unmatched flexibility, both now and in the future. Precision Spectra SCS System Unmatched LOW Back Pain Relief CoverEdge 32 Surgical Leads coupled with the Precision Spectra System provides unmatched low back pain relief. Precision Spectra is the ultimate therapy solution. Providing more coverage and flexibility, this system allows you to treat patients pain now and in the future. 9mm Low Back Pain Relief 50mm 8.3 = 6.1 CoverEdge 32 Surgical Lead is designed for seamless coverage. NRS 10mm mm Baseline (N=26) 12 Months (N=25) Infinion 16 Contact Lead LUMINA Surgical Data Precision Spectra offers Image Ready MRI Technology providing patients access to MRI Head Scans. CoverEdge 32 Surgical Lead CoverEdge X 32 Surgical Lead offers unmatched vertebral span. Ground-Breaking Low Back Pain Relief at 12 Months Pilitsis et al., NANS 2015
6 precision Montage MRI SCS System Successful outcomes with the illumina 3D portfolio Safe Full-Body MRI Access * The equation to a successful outcome is simple. Identify the Right Neural Target, then apply the Right Waveform to Customize Therapy for each unique patient. For patients needing access to Full-Body MRI Scans, Precision Montage has them covered. Find the RIGHT TARGET Apply the Right Waveform Full-Body MRI Access * Multiple Waveforms Powered by Illumina 3D + *under specified conditions Precision Novi SCS System Illumina 3D MultiWave Technology Smallest High Capacity Primary Cell Only the Illumina 3D Portfolio can customize therapy by delivering multiple waveforms to a precise neural target. Available in 3 devices to meet the unique needs of your patients. For patients who would benefit from not having to charge, Precision Novi delivers. Smallest High Capacity Primary Cell No Implant Depth Restriction Powered by Illumina 3D More Coverage and Flexibility Full-Body MRI Access * Non-Rechargeable *under specified conditions
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