de modèle : ACCK5xxx), une prise IPG (ACCK7000) et le générateur d'impulsions implantable Senza (n. Please note that the following components of the Senza system are . o. The second part of this booklet explains how to use the devices. . November 5, 2019 By Sean Whooley. Version (Model) Number: NIPG2000. The potential risks of performing MRI on patients with an implanted Senza system include: - Device movement - Excessive heating of or around the implanted device components - Tissue damage - Damage to the device - Uncomfortable sensation - Image artifact . Physician Implant Manual 11051 Rev D. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. Medical device company Nevro has received CE mark approval for the Senza Omnia Spinal Cord Stimulation (SCS) system. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025 USA Tel: +1. If you have any questions, please contact Nevro at the address or phone number at the end of this document. Nevro's battery is designed to last 10+ years at all common programming settings. o. SENZA®, SENZA II® and 1. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it has received CE Mark for full-body magnetic resonance imaging (MRI) conditional. The safety of HFX has been thoroughly studied and proven. The physician hit the nerve root and the patient was in. . Your MRI Tech will confirm the results before your MRI. This means that patients with the Axonics SNM System can safely have MRI examinations of any body part under certain conditions. products, including any serious incident that has occurred in relation to the device, should be forwarded to: Nevro hereby declares that the SENZA®, SENZA II®, and SENZA Omnia™ are in compliance with the essential requirements and other relevant provisions of the Radio Equipment Directive (2014/53/EU). Neurostimulation System. The Senza, Senza II, and Senza Omnia Systems should not be used for those patients who: • Are poor surgical candidates, including those with poor glycemic control in whom the safety of the device has not yet been characterized, i. Jude/Abbott, and Stimwave have all developed SCS models that are labeled full body MRI conditional. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. Brand Name: Nevro. Background With growing numbers of patients receiving deep brain stimulation (DBS), radiologists are encountering these neuromodulation devices at an increasing rate. Nevro (NYSE:NVRO) said yesterday that the FDA approved MRI-conditional labeling for its Senza spinal cord stimulation system designed to deliver HF10 therapy. All was well until a week ago when I started to experience pain at the battery implant site. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic. 650. connect to the implan ted IPG. Se tiver perguntas, contacte a Nevro através da morada ou do número de telefone indicados no fim deste documento. An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e. Bench top tests have shown that. . Magnetic Resonance Imaging (MRI) - The Senza system is MR. HbA1C >10%. Safety Topic/Article: The application of a scleral buckle (note, this is a procedure not an implant) or "scleral buckling" is a surgical technique used to repair retinal detachments and was first used experimentally by ophthalmic surgeons in 1937. S. Hfx is a comprehensive solution that includes a. Setup instructions, pairing guide, and how to reset. Os componentes implantados do sistema Senza podem incluir os elétrodos percutâneos (Modelo n. WARNINGS Warnings are statements about safety of your device that you should take very seriously. • Non eseguire un esame MRI con uno stimolatore di prova (TSM). Nevro HFX TM Guide Email or print this guide now and bring it to your next appointment. Email: info@nevro. “Our R&D and regulatory teams worked hard to secure this approval for both current and future Senza patients,” says Rami Elghandour, president and CEO of. Ask a lawyer - it's free! Browse related questions. com . . It is important to read this full document prior to conducting or recommending an MRI examination on a patient with the Senza system. 5. Important safety, side effects, and risks information. Every person is unique, and your medical needs differ from those of others, even people with the same condition and the same SCS system. 956. 2. *Within conditional parameters. Fax: +1. Intuitive functionality to enhance the patient experience and improve ease. Nevro Corp. products should be forwarded to: Nevro Corp. 437):Hi I am new here but 9 months post Nevro senza implant. Class action. Version (Model) Number: NIPG1500. 1800 Bridge Parkway Redwood City, CA 94065 USA 1. Nevro Receives CE Mark for Full-Body MRI Conditional Labeling with the Senza® Spinal Cord Stimulation System 11/15/2017 Expanding Patient Access to Nevro's HF10 Therapy through Broader Imaging Compatibility REDWOOD CITY, California , Nov. 650. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. (3T has severe limitations. NIH Device Record Key. ContraindicationsFull body conditional MRI labeling; Upgradable to future waveforms and frequencies; Omnia Clinician Programmer. GENERAL INFORMATION Device Generic Name: Stimulator, Spinal-Cord, Totally Implanted for Pain Relief Device Trade Name: Senza® Spinal Cord Stimulation (SCS) System . If you don’t have your patient ID card, please call your HFX Care Team for assistance. 02789812-3f3c-4164-940d-291c85d741e5. Spinal cord stimulation was approved by the U. The contraindications associated with performing MRI on patients with an implanted Senza system include: - Do not use the transmit RF body coil for 1. The second lead was introduced with difficulty. FCC CFR 47 Part 15. Magnetic Resonance Imaging Safety Status: MR CONDITIONAL: Indicates the MRI Safety. g. (NYSE: NVRO), a global medical device company Product Name: Senza Spinal Cord Stimulation (SCS) System PMA Applicant: Nevro Corporation Address: 1800 Bridge Parkway, Redwood City, CA 94065 Approval Date: July 16, 2021 Approval Letter. 5T and 3T imaging. 5. Nevro Corp. s28. Refer to the Information for Prescribers (P/N 10001223) for indications, contraindications, warnings, warnings about other medical treatments, precautions,. To learn more about filing a spinal-cord stimulator implant lawsuit, please call (888) 994-5118. . Magnetic Resonance Imaging (MRI) - The Senza system is MR. 1800 Bridge Parkway. PATENT NUMBER ISSUE DATE TITLE; CN ZL201780019179. Tell the doctor who requested the MRI scan that you have an implanted spinal cord stimulation device 2. Skin irritation may develop near the generator related to charging. Product Manuals for Healthcare Professionals. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ≥65% of patients across six peer-reviewed clinical studies. Learn More about the Nevro SCS systems at #NevroHFX #ChronicPain. This document is a supplement to the Senza system Physician Implant and Patient Manuals and is related only to the use of a transmit/receive radio frequency (RF) head or local coils of a 1. . Refer to Senza MRI Guidelines for detailed information on MRI safety and conditions. 0005 Fax: +1. . The Senza System has a very similar safety profile to other SCS devices that have been available for many years. If you need more information about compatibility with MRI scans, please refer to the Patient Manual, and consult with your doctor, or contact Nevro’s Technical Services department at [email protected] or. os. By the early 1960s, scleral buckling became the method of choice when the development of new. Bring your patient ID card and Remote Control to the MRI appointment. Nevro Corporation, Risks Associated with MRI with Senza System . 251. RestoreAdvanced SureScan MRI, Model 97713. . Pediatric Use - The safety and effectiveness of spinal cord stimulation has not been established for use in children. * If you need more information about compatibility with MRI and CT scans, please contact your Nevro HFX Care Team at 1-888-895-8105. The SENZA-RCT Randomized Controlled Trial. 3 . It is always the provider’s responsibility to determine theThe Senza system was the initial IPG from Nevro Corporation and was the first to offer 10 kHz, paresthesia-independent stimulation for the treatment of chronic pain . 5 T MRI and with 3. Conditional 5 More. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that it has received approval from the U. 1800 Bridge Parkway Redwood City, CA 94065, USA. (NYSE: NVRO ), a global medical deviceNevro, a company based in Menlo Park, California, won FDA approval for its Senza spinal cord stimulation system. 5T Highly Preferred. Bühne frei für Senza. erfolgt unter Lizenz. But when you have an implanted device, you have to be careful about MRI scans. Our SCS systems are now approved to deliver 2. Global Unique Device ID: 00813426020572. According to the company, the Senza II system offers the superior outcomes and clinical advantages of HF10 therapy through a smaller and more refined footprint while. Nevro® SENZA® (IPG1000, IPG1500) SENZA II® (IPG2000) SENZA Omnia™ (IPG2500) Boston Scientific® Precision Montage MRI (SC-1200) Wavewriter Alpha (SC-1232, SC-1216). I understand these communications may include advertisements for goods and I can unsubscribe at any time. Willard Daniel 08 Jul 2023. Stimulation between 1,200 Hz and 10,000 Hz has not been evaluated for safety, Patient Manual. g. Precision Montage™ MRI SCS System. Any serious incident that occurs in relation to the device should be forwarded to Nevro Corp. V. Magnetic Resonance Imaging (MRI) - The Senza system is MR. 7 million in Q1 2015, up 70% at constant currencies. Senza Spinal Cord Stimulation System, Nevro Corporation: 1 Neurostimulation System: Pulsante SPG (Sphenopalatine Ganglion. NEVRO CORP. The company provides solutions for the treatment of chronic pain. The system is capable of delivering 10kHz therapy, a therapy that does not produce tingling sensations called paresthesia. All questions…Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic. Posted by elsa @elsa, Jul 26, 2020. 4. 7. . Nevro's SENZA-NSRBP study compares Nevro's proprietary high-frequency (10 kHz) SCS plus CMM to CMM alone in 159 randomized patients at 15 study centers. 15, 2017 /PRNewswire/ - Nevro Corp. Spinal cord stimulator restrictions have three goals: 1. It was reported to nevro on (b)(6) 2015 that a patient was sent to the er after a trial procedure. Urgent Field Safety Notice . An electrode: this sits in the epidural space and delivers very small and precise currents. Worldwide, tens of thousands of. Appendix: SENZA System MRI Scan Checklist This checklist is provided as an optional resource to support MR centers in conducting and MRI of a patient implanted with the Nevro SENZA system. Company Name: NEVRO CORP. A. inside the body (see IPG in the diagram above). Nevro Corp. All questions or concerns about Nevro Corp. 1800 Bridge Parkway Redwood City, CA 94065 U. Company/Org Logo: About Company: Headquartered in Redwood City, California, Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. comNevro, a firm based in Silicon Valley, won FDA approval for its Senza Omnia spinal cord neurostimulation system for chronic pain management. Nevro (NYSE: NVRO ) said yesterday that the FDA approved MRI-conditional labeling for its Senza spinal cord stimulation system designed to deliver HF10 therapy. MR Unsafe:More Frequency and Waveform Versatility. Nevro Hf10 Mri Guidelines. NEVRO CORP. . 1. Minimal restrictions and reversible. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). Nevro Corporation Anshul Shah Senior Manager, Regulatory Affairs 1800 Bridge Parkway Redwood City, California 94065 Re: P130022/S042 Trade/Device Name: Senza® Spinal Cord Stimulation (SCS) System Product Code: LGW Filed: July 22, 2021 Dear Anshul Shah:. . Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Risks Associated with MRI with Senza System . 2. More . Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. D. o: ACCK5xxx), ficha para tomada de IPG (ACCK7000) e o gerador de impulsos implantável Senza (Modelos n. HFX permits full body MRI scanning under certain conditions. 11, 2022 /PRNewswire/ -- Nevro Corp. Guidelines. Stimulation at vertebral levels above T8 â Safety of Nevro SCS system at >2kHz to10 kHz program settings above the T8 vertebral level has not been studied. 650. Conclusion. Ability to provide or blend 2 distinct mechanisms of action. SENZA®, SENZA II® and SENZA. IMPORTANT: Do not change or modify any component of the Senza ® TMHFX iQ. I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. - Many. (NYSE: NVRO) and Boston Scientific Corp. Please note that the following components of the Senza system are . You control the implanted device with the same Remote Control. . and is capable of stimulating the spinal cord nerv es when used with one or more leads. 12. More. NEVRO CORP. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. , lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or. . (NYSE: NVRO), a global medical device company delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced a series of data presentations supporting the use of the company's HFX™ 10 kHz Therapy for patients with chronic pain. Rückenmar Pin. Nevro Corp. Pediatric Use - The safety and effectiveness of spinal cord stimulation has not been established for use in children. ‐ Low SAR mode; SAR set based on device instructions. TM. Fax: +1. Bring your patient ID card and Remote Control to the MRI appointment. 1. • Non eseguire un esame MRI in presenza di elettrocateteri orfani o di altri elettrocateteri non collegati al generatore Nevro Senza® IPG nel paziente. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. Patient Manuals and MRI Guidelines. Safety Topic / Subject. . Senza HFX iQ is the first. . Nevro (n. Was on opiates for 8 years until I attended & graduated from Mayo's 3-week Pain Rehab Program in 2018. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. 650. Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801. AJR Am J Roentgenol. It indicates a way to close an interaction, or dismiss a notification. Prospective Patient Education and Existing Patient SupportSenza is the First Implantable Spinal Cord Stimulator System that is 3 Tesla MRI Compatible. Medicare accepts the below C-codes. : +1. Tel. DEVICE DESCRIPTION The Senza SCS System is a totally implanted device that delivers electrical stimulation to the dorsal column of the spinal cord for the treatment of chronic intractable pain of the trunk and/or limbs. 1 Doctor Visit Discussion Guide Email or print this guide now and bring it to your next appointment. o. Expanding Patient Access to Nevro's HF10 Therapy through Broader Imaging Compatibility REDWOOD CITY, California , Nov. Contraindications Full body conditional MRI labeling; Upgradable to future waveforms and frequencies; Omnia Clinician Programmer. . Pediatric Use – The safety and effectiveness of spinal cord stimulation has not been established for pediatric use. Other trademarks and trade names are those of their respective owners. Contraindications Associated with MRI with Senza System. . If the Senza system is right for you, your doctor will then implant the IPG. In the back of the booklet, we have added some information in the appendices. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. 650. Excerpts Pertaining to the Joint Commission’s (TJC) Revised Requirements for Diagnostic Imaging Services Related to MRI Safety: 1 Ellipse Implantable Cardioverter Defibrillator (ICD) System, St. . YOU ARE ABOUT TO EXIT FOR A WEBSITE INTENDED FOR THE RESIDENTS OF ANOTHER COUNTRY OR REGION. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for Senza® HFX iQTM System. After a trial period of about a week, if the patient is achieving good results the device is implanted in the person. The company also offers a newer system called Senza II, which delivers the same HF10 therapy. For thiswe thank you for your continued support of Nevro. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the Senza System (IPG1000 and IPG1500) ONLY MRI Guidelines 11096 Rev D. DRAFT 16. Version (Model) Number: NIPG2500. Furthermore, it is not intended to increase or maximize reimbursement by any payer. 1 found this answer. Please note that product literature varies by geography. The Nevro ® Senza ® SCS System for 10 kHz Therapy received CE mark in 2010, FDA approval in 2015, and is commercially available in Europe, Australia, and the United States. MENU. 5 T MRI and with 3. An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e. Nevro recommends reviewing commercial contracts and medical policies to determine if it is appropriate to bill certain HCPCS codes described herein. 11095 Senza System 1. 3. to protect your safety. The Senza SCS. 251. 6. MR Unsafe:The implanted components of the Senza system may include Nevro percutaneous leads (LEAD10x8-xx(B)), lead extensions (LEAD2008-xx(B)), lead anchors (ACCK5xxx), IPG port plug (ACCK7000), and the Senza implantable pulse generator (NIPG1000 or NIPG1500). 6 %âãÏÓ 3336 0 obj > endobj 3349 0 obj >/Filter/FlateDecode/ID[3651EB410DB58C4E9995BAFCDE71FA43>10FD656D46DEC54BBC783011D5ABC736>]/Index[3336 21]/Info 3335. Company Name: NEVRO CORP. 437): No Device labeled as "Not made with natural rubber latex": No For Single-Use: No Prescription Use (Rx): No Over the Counter (OTC):Nevro Headquarters Nevro Corp. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. • Passing Elevator Accessory Tool: The Passing Elevator Accessory Tool is an optional surgical accessory tool, intended to assist implanting physicians in assessing and verifying that the epidural space is appropriately sized for. Device Name: Senza® IPG Kit. **Battery data accurate as of 2021. It is important to read the entire SENZA System MRI Guidelines manual (11096) prior to conducting an MRI scan. Safety Info ID# Safety Topic / Subject Article Text 356: Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation: Neurostimulation System:. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. Contraindicationshave questions about whether the Senza system may be right for you, ask your doctor. Food and Drug Administration in 1984. Medical device firm Nevro has secured approval from the US Food and Drug Administration (FDA) for its Senza Omnia spinal cord stimulation (SCS) system to treat chronic. NEVRO ON-LABEL DIRECT CONNECTION Connect compatible Nevro leads directly to any Boston Scientific IPG: The Boston Scientific Direct Connection is compatible with the following Nevro leads and lead extensions: Blue Lead Extension Kit Model LEAD2008. Nevro Corp. It is also capable of providing stimulation that producesMedical device company Nevro has launched Senza Omnia Spinal Cord Stimulation (SCS) System to treat chronic pain in the US, following the US Food and Drug Administration (FDA) approval. Table of Contents INTRODUCTION. Refer to Nevro HFX MRI Guidelines for detailed information on MRI safety and conditions. Ihr HFX™ Gerät ist unter bestimmten Bedingungen für Ganzkörper-MRT-Untersuchungen zugelassen. 5, 3. . WARNINGS Warnings are statements about safety of your device that you should take very seriously. . 8 | LOSS OF MRI-CONDITIONALITY IN SPINAL CORD STIMULATORSThis is a comprehensive solution that includes a Senza® spinal cord stimulation system and support services for the treatment of chronic pain. 187. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility managers, and others. Object Description. . Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-month. Pediatric Use - The safety and effectiveness of spinal cord stimulation has not been established for use in children. Nevro's proprietary 10 kHz Therapy has demonstrated the ability to reduce or eliminate opioids in ≥65% of patients across six peer-reviewed clinical studies. The IPG is implanted in a subcutaneous pocket. No other spinal cord stimulation (SCS) technology has this wealth of quality clinical data to back its. Brand Name. Version (Model) Number: NIPG2500. This approval is retroactive, meaning that the new labelling for expanded imaging applies to all patients currently implanted with the Senza SCS System with percutaneous leads. MR Conditional . Indications for Use: The Senza®, Senza II™ and Senza Omnia™ neuromodulation systems are used as aids in the management of chronic intractable pain of the trunk and/or limbs. Spinal Cord Stimulation (SCS) System: Abbott and St. Quick, outpatient & minimally invasive. The Omnia system is. MRI safety survey. Effective November 2022. 12-Month NSRBP RCT results published in the Journal of Neurosurgery: Spine. The conditions for MRI scans will vary with the type of transmit. Senza II is intended for use in patients with a lowNevro Headquarters. . Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of. Appendix: SENZA System MRI Scan Checklist This checklist is provided as an optional resource to support MR centers in conducting and MRI of a patient implanted with the Nevro SENZA system. . 9415 [email protected] Senza Spinal Cord Stimulation System Nevro Corporation, Strength 1. The device can deliver traditional spinal cord. The camera never lies!!! To everyone going through this journey, its not easy, there are many decisions to make. is under license. Commercial Distribution Status. A. National Hospital for Neurology and Neurosurgery. q4cdn. In the future, you may need magnetic resonance imaging (MRI) to diagnose an illness. I had my Nevro HF10 implanted 1 month ago and I now have a Serious Infection and seeing an Infectious Disease Dr. Nevro Corp. The following are some warnings for the Senza system:The authors noted that pathologic findings were equal with 1. Data from last assessment, average 17. Krishnan Chakravarthy serves as a consultant to Abbott, Medtronic, Bioness, SPR Therapeutics, Nalu Medical, Omnia Medical, and Saluda Medical; founder of Newrom. 251. 9415 [email protected] Fax: +1. 1. Your device is therefore a restricted device. If you do not follow these warnings, it is possible that you could be hurt and/or the device could be damaged. Nevro stimulator senza hf10 stories effective rated courtesy latest pain bioworld term Nevro hf10 accessory manuals pdf download (a) neurological function scores at 24 h after ca/cpr. . , et al. Nevro HFX Care Team support. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. April 30th, 2021 . (3T has severe limitations. 12-Month durability and crossover results published in Diabetes Care. MRI COMPATIBILITY. , lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or. Article Text. The Senza®, Senza II™ and Senza Omnia™Senza is the First Implantable Spinal Cord Stimulator System that is 3 Tesla MRI Compatible Nevro Corp. ContraindicationsSenza is the First Implantable Spinal Cord Stimulator System that is 3 Tesla MRI Compatible Nevro Corp. THE List. . Allows for the delivery of 2-1200 Hz & 10,000 Hz frequencies in. HFX iQ is the only SCS system that uses Artificial. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that it has received approval from the U. MRI system type. The short answer is yes, it’s possible but- it depends on which spinal cord stimulator device you choose. Nevro has developed and commercialized the Senza. Company Name: NEVRO CORP. Model(s): SC-1200; MRI Full Body Patient Eligibility Checklist . The system is capable of delivering HF10® therapy, a therapy that does not produce tingling sensations called paresthesia. 251. If you do not follow these warnings, it is possible that you could be hurt and/or the device could be damaged. . products should be forwarded to: Nevro Corp. Find a Doctor. Neurostimulation is not right for everyone. This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. S. Lead, instead of connecting to an external stimulator as occurred during the trial phase, will. Removing limitations for patients, the Senza Trial Stimulator offers a sleeker, more contoured single-use device, plus cable-free Bluetooth ® capability equals outstanding patient comfort and discretion. M8 and S8 Adaptors . The implanted neurostimulation system allows the patient to be eligible to have MRI scans of any part of the body under specific conditions. The Nevro® ®Senza BLUETOOTH® enabled Spinal Cord Stimulator (SCS) Trial System works by delivering electrical energy from a stimulator to an area around the spine. c488b2ec-7692-41e0-9d08-7f6942b94fbb. 5T and 3T MRI Guidelines Rev C Page 5 Introduction Nevro’s Senza Spinal Cord Stimulation (SCS) system is an MR Conditional device that has been demonstrated to present negligible hazards in a specified MR environment when following specificImportant safety, side effects, and risks information. Omnia.