The Boston Scientific Radiofrequency Generators, associated Radiofrequency Lesion Probes and RF Cannula are indicated for use in procedures to create radiofrequency lesions for the treatment of pain or for lesioning nerve tissue for functional neurosurgical procedures. RECOVER trial will provide thorough understanding of VNS response in depression patients, Office-based removal of sacral neuromodulation devices deemed safe and well-tolerated, Evidence indicates effectiveness of brain stimulation in upper-limb stroke rehabilitation, InbrainNeuroelectronicssecures funding for AI-powered graphene-brain interface. References: 1. News; Careers; . As measured by the Oswestry Disability Index at 3 months post implant. Based on the pain area(s) chosen, you may not be qualified for one of our pain management solutions at this time. Boston Scientifics ImageReady MRI Technology makes safe MRI head scans possible. This stimulation does not get rid of whats causing the pain. Your doctor may be able to provide additional information on the Boston Scientific Spinal Cord Stimulator systems. Spinal Cord Stimulator (SCS) systems device support; See all Pain management Women's health. 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. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. The Boston Scientific Spinal Cord Stimulator 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, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. 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: The SENZA-RCT Randomized Controlled Trial. Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations. Pain . Every chronic pain patientand how he or she responds to any specific treatmentis unique. Metzger et al, Outcomes Using an SCS Device Capable of Delivering Combination Therapy and/or Advanced Waveforms/Field Shapes, INS 2019. SCS therapy is used to treat different kinds of chronic pain pain lasting six months or more. See details highlighted below. PDF Summary of Safety and Effectiveness Data (Ssed) All rights reserved. Deliver effective, personalized relief solutions for your patients with back, neck, shoulder, leg, or lower limb pain. The unified portfolio of four MRI conditional, Bluetooth-enabled rechargeable and non-rechargeable implantable pulse generators (IPGs) provides uncompromised personalization, and for the first time in SCS, Fast Acting Sub-perception Therapy (FAST) designed to deliver profound paresthesia-free pain relief in minutes.iThe systems are supported by theCognita Solutions suite of digital tools for patients and physicians. Do not expose the Remote Control or Charging System components to excessively hot or cold conditions. Be sure to talk with your doctor about these risks. Explore the different kinds of pain so that you can most effectively communicate with your doctors. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. Male Residue from soapy detergents should be removed with a cloth lightly dampened with water. Medical iPhone. See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information. The ability to deliver multiple therapies simultaneously * is unique to Boston Scientific SCS Systems and has been clinically proven to provide greater pain relief. For more information, visit www.bostonscientific.comand connect on Twitterand Facebook. These events, which may include device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control. Neurosurgery. Indications for Use: The Superion Indirect Decompression System (IDS) is indicated to treat patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis. Safe Boston Scientific Freelink SC-5270 Directions For Use Manual health of patients around the world. Email: [emailprotected] Anesthesiology 2015; 123:851 -8606. The Superion Indirect Decompression System (IDS) is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, having radiographic evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. Information provided for educational purposes only. North et al., WHISPER RCT, Neuromodulation 2019. Patients implanted with Boston Scientific Spinal Cord Stimulator Systems without ImageReady MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). 21. Warnings. These forward-looking statements include, among other things, statements regarding our business plans and product performance and impact. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. Effective sub-perception therapy requires accurate targeting and dosing of the stimulation field. 1 SCS sends electrical impulses that trigger nerve fibers along the spinal cord, masking the pain message traveling to the brain. Your doctor may be able to provide additional information on the Boston Scientific Spinal Cord Stimulator systems. Pain Medicine Products> Spectra WaveWriter SCS System. Thomson et al, PROCO RCT, Neuromodulation 2018. The Remote Control, External Trial Stimulator and Programming Wand can be cleaned using a mild detergent applied with a lightly dampened cloth or tissue. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 4. Connect. Gilbert et al., Computational modeling predicts dorsal columns are involved in fast-acting sub-perception spinal cord stimulation (SCS). The Spinal Cord Stimulator 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 candidates, or are pregnant. Associated conditions and etiologies may be: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, multiple back surgeries. Refer to the Limited Warranty for additional information. Tag deactivators such as those found in retail stores and libraries. (N=70) 2. Disadvantages and Risks of Spinal Cord Stimulation With 16 contacts and 16 dedicated power sources, Precision Plus allows you to precisely target pain in increments of 0.04 mm - the width of a human hair. (N=41) 3. document.getElementById( "ak_js_1" ).setAttribute( "value", ( new Date() ).getTime() ); Write to us Full stimulation parameter ranges and options for both paresthesia-based and subperception therapy are available for clinicians use throughout the patients experience and treatment with SCS. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Chronic pain is defined as continuous and long-term pain lasting more than 12 weeks. Now that you know more about the options available to you, let our specialists guide you on your next step. This is in contrast to the NC Balloon, which shows a much lower stress distribution when used at the same 12 ATM inflation pressure. If using therapy that does not produce a sensation (subperception), postural changes are less likely to affect the patient. FAST MOA computational modeling by Dr. Warren Grills lab at Duke University. Boston Scientific's proprietary FAST therapy is designed to provide immediate paresthesia-free pain relief by targeting a new and distinct SCS mechanism of action revealed through a multi-year research collaboration with Duke University. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the If patients notice excessive redness around the wound areas during this time, they should contact their physician to check for infection and administer proper treatment. If any of the above is required by medical necessity, refer to Instructions for the Physician in the DFU. Professionals; Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Patients implanted with the Precision Spectra or Spectra WaveWriter Spinal Cord Stimulator Systems with ImageReady MRI Technology are ""MR Conditional"" only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady MRI Head Only Guidelines for Precision Spectra or Spectra WaveWriter Spinal Cord Stimulator Systems. Are you currently being treated by a pain management specialist? For therapy that does not generate paresthesia (e.e., subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. Female Burns may result if the pulse generator case is ruptured or pierced and patient tissue is exposed to battery chemicals. Order Vertiflex Procedure Information Kit. Although reliability testing has been performed to ensure quality manufacturing and performance, dropping the devices on hard surfaces or in water, or other rough handling, can permanently damage these components. Spinal Cord Stimulator (SCS) systems device support; See all Pain management Women's health. Thin, flexible leads are connected to the spinal cord stimulator and placed near specific nerves in the back. In some cases, the skin over the Stimulator may become very thin over time. The Superion Interspinous Spacer may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5. There are potential risks involved with any procedure. All rights reserved. Advancing Science for Life - US - Boston Scientific Boston Scientific Spectra Wavewriter DFU (ARTEN600017308 A). This can help with pain reliefeven when other therapies have failed. 2023 Boston Scientific Corporation or its affiliates. While traditional paraesthesia-free therapy can take up to a few days to achieve pain relief, FAST is designed to allow patients to experience paraesthesia-free pain relief in minutes. 65 and over BIBA Medical, North America "Combined with our family of innovative and proven solutions for the treatment of chronic pain, including the Vertiflex Procedure and radiofrequency ablation, we are helping physicians provide treatments that span the continuum of care so patients can find access to the medical support they need to live better lives.". The stimulator delivers tiny pulses of mild electric current through the leads to specific nerves on the spinal cord. The following medical therapies or procedures may turn stimulation off or may cause permanent damage to the Stimulator, particularly if used in close proximity to the device: X-ray and CT scans may damage the Stimulator if stimulation is on. Once you have your Boston Scientific SCS System, youll begin your next chapter of life with Boston Scientific on your side. Patients using mySCS with a Boston Scientific device are more likely to have a successful trial 1. . Give your patients access to learning resources and a direct connection with our SCS patient education team. Medtronic Intellis Implant Manual (M946871A002 Rev C). The possible risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation include: In any event, instruct the patient to contact their physician to inform him/her. Women's health; See all Women's health . You should consult your pain management specialist to determine what treatments are right for you. The WaveWriter Alpha SCS system was launched last year and is indicated as an aid in the management of chronic intractable pain. Boston Scientific WaveWriter Alpha SCS system IPG rechargeable battery could provide at least five years and up to 25 years or more service. Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting, Realistic goal setting to better assess trial outcome, See all healthcare professional information, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, Patients and Caregivers - Support and Resources, Do not sell or share my personal information, Patient education resources for more clarity on the trial experience, Daily reminders to increase patient compliance, Alerts for early communication when needed, Data-driven insights to optimize permanent implant, Available on tablets and personal computers (in addition to mobile devices). The operating temperature of the Trial Stimulator, Remote Control, and Programming Wand is 1040 C (50104 F). My age is Hundreds of thousands of people worldwide have been treated with SCS. The Superion Interspinous Spacer is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain, who have undergone at least 6 months of non-operative treatment. SCS systems have a small implanted pulse generator, called a stimulator, and thin wires called leads. Find out who we are, explore careers at the company, and view our financial performance. Discover more about the different kinds of treatment and the doctors who will try to help you manage your pain. Boston Scientific Spectra Wavewriter DFU (ARTEN600017308 A). In April 2014, Boston Scientific's Precision stimulator was implanted in Taft by Jason Highsmith, a Charleston, South Carolina, neurosurgeon who has received $181,000 from the company over the past five years in the form of consulting fees and payments for travel and entertainment. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Study Explores Deep Brain Stimulation for Stroke Patients Find products, medical specialty information, and education opportunities. Stimulation must be turned off first in such cases. Upon completion of the Patient Trial, remove the batteries from the Trial Stimulator. Boston Scientific - How SCS Works Animation - YouTube This treatment is for leg and lower back pain caused by lumbar spinal stenosis. Your doctor will help you choose which one is best for you. Weakness, clumsiness, numbness or pain below the level of implantation. The system should not be charged while sleeping. Find out who we are, explore careers at the company, and view our financial performance. The new CoverEdge Family of Surgical Leads, together with our broad percutaneous lead portfolio, offers you unrivaled flexibility to customize therapy to your patients, both now and in the future. **MRI conditional when all conditions of use are met. Patients should be advised that changes in posture or abrupt movements may cause decreases, or uncomfortable or painful increases in the perceived stimulation level. *Sub-perception stimulation has been demonstrated to be safe and effective in patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least six months. Boston Scientific can help you maximize your patients chances for successful therapy with mySCS. Spinal Cord Stimulator Systems - Boston Scientific Need an image of a Boston Scientific product? Contraindications, warnings, precautions, side effects. It starts with patient education and personalized goal setting, followed by simple progress tracking and real-time expert support. 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. 1 You have been suffering from pain for . We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. Medical BSC Expert Connect. MARLBOROUGH, Mass., Jan. 14, 2021 /PRNewswire/ -- Boston Scientific (NYSE: BSX) has announced a limited market release of the WaveWriter Alpha portfolio of Spinal Cord Stimulator (SCS) systems. *Paresthesia-free stimulation has been shown to be safe and effective in patients who have been treated successfully with paresthesia-inducing stimulation for at least 6 months. About Boston ScientificBoston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. Spinal Cord Stimulation Trial | NeuroSpine 2023 Boston Scientific Corporation or its affiliates. Its what helps you., I really feel that my pain relief has been personalized to me just because of the different settings that I have with my stimulator., The settings can be ones where you can feel the paresthesia or you dont feel anything at all. Based on your answers, you may be a candidate for: You should consult your pain management specialist to make a final determination. Possible surgical procedural risks are: temporary pain at the implant site, infection, cerebrospinal fluid (CSF) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis. It felt like I had a new lease on life., Talk to a real patient living with SCS therapy. On a scale from 1 to 10, with 1 representing minimal and 10 being most severe, rate your personal pain. Spinal Cord Stimulation, or SCS, may offer hope for many of the estimated 100 million people who suffer from chronic pain. Get the latest news on innovative pain management solutions from Boston Scientific delivered right to your inbox. Pain management specialists are doctors who specialize in all kinds of pain. subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment. At the end of your trial you can review your . Track your pain, learn about treatments, and generate progress reports.

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