DRAFT 16. 1. Data from last assessment, average 17. Hfx is a comprehensive solution that includes a. What MRI safety information does the labeling contain?. **Battery data accurate as of 2021. 5T and 3T MRI . Nevro® SENZA®, SENZA II® and SENZA Omnia™ Spinal Cord Stimulation (SCS) implantable pulse generators (IPG) are MR Conditional devices that have been. Budet. Safety Important Safety Information 10 kHz Therapy and other available SCS frequencies and waveforms are delivered by Senza Spinal Cord Stimulation (SCS) systems. All questions or concerns about Nevro Corp. Refer to Senza MRI Guidelines for detailed information on MRI safety and conditions. 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. Medical device company Nevro has received CE mark approval for the Senza Omnia Spinal Cord Stimulation (SCS) system. Device Name: Senza Omnia IPG Kit . 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025, USA Tel: +1. 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. This is just one spinal cord stimulation review on the Nevro SCS system specifically. Jennifer was just 19 when her painful journey began as a result of injuries. Device Procode: LGW . Nevro® SENZA®, SENZA II® and SENZA Omnia™ Spinal Cord Stimulation (SCS) implantable pulse generators (IPG) are MR Conditional devices that have been demonstrated to present no known hazards in a specified MR environment when following specific guidelines as described in this document. Company Name: NEVRO CORP. 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. , lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to. You can We would like to show you a description here but the site won’t allow us. Programmers will display one of the icons below to indicate MRI eligibility based on the patient’s SCS system. com MDSS GMBH Schiffgraben 41 D-30175 Hannover, Germany Australian Sponsor Emergo Asia Pacific Pty Ltd The Senza System has a very similar safety profile to other SCS devices that have been available for many years. TM. The cost for a spinal cord stimulator is much like any medical procedure or surgery, costs vary from person to person. 15, 2017 /PRNewswire/ -. Your device is therefore a restricted device. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. Worldwide, tens of thousands of patients are enjoying more freedom and improvement in their daily lives with Nevro products. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. 3876 Nevro. . The Senza and Senza II Systems are implantable systems and deliver stimulation using implantable leads. 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 specificRisks Associated with MRI with Senza System . 4. Senza system and safety and effectiveness data. . p: +1-650-251-0005. (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 now initiated the U. . os: NIPG1000 ou NIPG1500) da Nevro. IMPORTANT: Do not change or modify any component of the Senza ® HFX iQ. 0005 . de modèle : NIPG1000 ou NIPG1500). Reported issues include infections, sepsis, shocking sensations, and numbness. , March 22, 2018 /PRNewswire/ -- Nevro Corp. It is important to read this full document prior to conducting or recommending an MRI examination on a patient with the Senza system. to protect your device. It is important to read the entire SENZA System MRI Guidelines manual (11096) prior to conducting an MRI scan. 3 . Your MRI Tech will confirm the results before your MRI. Omnia. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). g. , 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. 1. Minimal restrictions and reversible. . Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. Commercial Distribution Status. The Omnia system is the first and only. . Other Active Implanted Devices – The Senza and Senza II systems may interfere with other implantedREDWOOD CITY, Calif. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System, Neuromodulation System. 7: Sep 13, 2022: Treatment of Congestive Heart Failure With Electrical Stimulation, and Associated Systems and MethodsSafety Topic/Article: The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated to present no known hazards in a specified MRI environment when following specific guidelines as described in the 1. Nevro Corp. 5 Risks Associated with MRI with Senza System. After back surgeries, injections, physical therapy and pain medication failed to relieve the back pain Jennifer suffered with for almost 20 years, Jennifer was feeling hopeless until she discovered HFX* and consulted Dr. MRI uses powerful static magnetic field, gradient magnetic fields, and RF energy to construct an image of a section of the body. Medgadget nevroStimulator spinal fda cleared eisner fri Nevro hf10 breakthrough chronic minimally invasive addictive 3tvNevro (hf10 therapy). The short answer is yes, it’s possible but- it depends on which spinal cord stimulator device you choose. 5, 3:Nevro today announced it has received approval from the US Food and Drug Administration (FDA) for the Senza Omnia spinal cord stimulation (SCS) system. Fax: +1. MR Conditional . SENZA®, SENZA II® and 1. 7 million in Q1 2015, up 70% at constant currencies. Nevro® hereby declares that the Senza® HFX iQTM System and Senza® HFXTM Trial System is in compliance with the essential requirements and other relevant provisions of the Radio Equipment Directive (2014/53/EU) and U. , lumbar, truncal, in a limb). 15, 2017 /PRNewswire/ -- Nevro Corp. Brand Name. ) are receive only. wrist coil, knee coil etc. e-li mít dotazy, kontaktujte prosím společnost Nevro na adrese nebo telefonním čísle, které jsou uvedeny na konci tohoto dokumentu. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. Risks Associated with MRI with Senza System. . ‐ Low SAR mode; SAR set based on device instructions. . ContraindicationsFull body conditional MRI labeling; Upgradable to future waveforms and frequencies; Omnia Clinician Programmer. This Reimbursement Guide is an interactive PDF covering the common questions and barriers of reimbursement including the following sections: Coverage – Includes a Medicare Coverage Map and details on requirements of psychological evaluations and surgical consultations. 2 attorney answers. Omnia ist das einzige System, das entwickelt wurde um Frequenzen von 2 bis 1. 5T or 3T horizontal bore MRIMeaningful Evidence To Support Your Practice. 0T machines or vertical field orientation machines, as device damage, excessive heating of implanted components, and serious patient injury could occur. 5T and 3T imaging. Nevro Device Crosswalk by Product Code The following Nevro products have Level II HCPCS codes that can be billed on the UB-04 claim form. 1. Keith. I've lived with severe chronic pain in my legs and lumbar spine for the past ten years. ContraindicationsAn assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). This Reimbursement Guide is an interactive PDF covering the common questions and barriers of reimbursement including the following sections: Coverage – Includes a Medicare Coverage Map and details on requirements of psychological evaluations and surgical consultations. The Senza delivers Nevro’s proprietary HF10 therapy to help control chronic pain. (NYSE: NVRO), a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today announced that it has received CE Mark for. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Typically safer than other spine surgeries used to address chronic pain 1-5. 1. Commercial Distribution Status. These instructions only apply to the Senza system, and do not apply to other products. Food and Drug Administration (FDA) for the Senza ® Omnia ™ Spinal Cord Stimulation (SCS) System. Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801. 5. 2007;188(5):1388–94. 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. (3T has severe limitations. Contraindications have questions about whether the Senza system may be right for you, ask your doctor. Expanding Patient Access to Nevro's HF10 Therapy through Broader Imaging Compatibility REDWOOD CITY, California , Nov. It indicates a way to close an interaction, or dismiss a notification. Nevro® hereby declares that the Senza® HFX iQTM System and Senza® HFXTM Trial System is in compliance with the essential requirements and other relevant provisions of the Radio Equipment Directive (2014/53/EU) and U. The 4. Axonics MRI Patient Guidelines – United States 2 3. Noter que les éléments MR Conditional du système Senza . 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. Bench top tests have shown that patients implanted with Senza system can be safely exposed to MR environments specified in this guideline. It’s a small device, placed in a same-day, outpatient procedure, that safely works inside your body to significantly reduce your pain and restore your quality of life. Refer to Senza MRI Guidelines for detailed information on MRI safety and conditions. Nevro Corp. 5. You control the implanted device with the same Remote Control. IMPORTANT: Do not change or modify any component of the Senza ® TMHFX iQ System and Senza ®. (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. . 650. c488b2ec-7692-41e0-9d08-7f6942b94fbb. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. g. 1This booklet was written for people who are considering or have received a Nevro ® Senza ® BLUETOOTH ® enabled Spinal Cord Stimulator (SCS) Trial System to help treat pain. National Hospital for Neurology and Neurosurgery. Bench-top tests have shown that patients implanted with the Senza system can be safely exposed to MR environments specified in this guideline. RestoreAdvanced SureScan MRI, Model 97713. Nevro HFX, a next-generation approach, has been clinically proven to provide substantially more long-term pain relief compared to people with traditional spinal cord stimulators 6. Source: The implanted senza spinal cord stimulation (scs) system (nevro corporation) is mr conditional and has been demonstrated. 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. Redwood City, CA 94065 USA NEVRO CORP. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that data from the SENZA Painful Diabetic Neuropathy (PDN) Randomized Controlled Trial (RCT), the largest RCT to evaluate spinal cord stimulation (SCS) to treat. Our centre has recently made high-frequency spinal cord stimulators at 10 kHz (HF-SCS) the implant of first choice, over conventional alternatives, following the publication of data demonstrating superior efficacy []. NEVRO CORP. Nevro Corp. For United States of America. Webinar Learn About Nevro HFX + Hear From a Nevro HFX Patient YouTube Implantierbarer Neurostimulator Senza® Nevro Corp. S. Information provided by Nevro is presented for illustrative purposes only and is not intended to and does not constitute coding, reimbursement, legal, business, or other advice. • Non eseguire un esame MRI se gli elettrocateteri non sono collegati all'IPG o agli adattatori. A patient with Stryker Detachable Coils can be safely scanned immediately after placement of the coils, under the following conditions: Static magnetic field of 1. AccessGUDID - Senza (00813426020770)- Trial Stimulator 3500 Kit. Nevro's SENZA-PDN study, the largest RCT of spinal cord stimulation treatment conducted for PDN, compares 10 kHz SCS plus CMM to CMM alone in 216 patients at 18 centers in the United States. Sources. System and Senza ®. 5. Learn More. The system is capable of delivering 10kHz therapy, a therapy that does not produce tingling sensations called paresthesia. * If you need more information about compatibility with MRI and CT scans, please contact your Nevro HFX Care Team at 1-888-895-8105. Tel: +1. 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. Nevro has developed and commercialized the Senza. 6. . Senza HFX iQ™ uses a fixed set of instructions to provide optimized treatment recommendations that utilize direct patient input from assessments on pain and quality of life measures. They should only be exposed to MRI under conditions outlined in the instructions for use and the full-body MRI conditional label issued in November 2017. Safety Topic / Subject. It is also capable of providing stimulation that producesDRAFT Physician Implant Manual SenzaÂŽ Senza IIâ ˘ ONLY NEVRO CORP. studies of the Senza System and safety and effectiveness data. . Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. It is important to read the entire SENZA System MRI Guidelines manual (11096) prior to conducting an MRI scan. o. A. Tyto pokyny se týkají výhradně systému Senza a žádných jiných prostředků. o. 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 . Patient Manuals and MRI Guidelines. . Spectra WaveWriter Information for Prescribers Manual. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. The safety of HFX has been thoroughly studied and proven. . g. Object Category Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporatio. Risks Associated with MRI with Senza System . Brand Name: Omnia. (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. Nevro pursues clinical research to better support healthcare providers in treating chronic pain. Device Name: Senza® IPG Kit. 3. HFX iQ is a smart pain management system that uses the largest clinical SCS dataset to recommend the starting program most likely to provide pain relief 1 and adjusts therapy based on each patient's responses to maintain optimized relief. Company Name: NEVRO CORP. IMPORTANT: Do not change or modify any component of the Senza ® TMHFX iQ. Jude Medical More. Se tiver perguntas, contacte a Nevro através da morada ou do número de telefone indicados no fim deste documento. 251. 650. MENLO PARK, Calif. 1800 Bridge Parkway Redwood City, CA 94065 U. 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. Furthermore, it is not intended to increase or maximize reimbursement by any payer. . Refer to Nevro HFX MRI Guidelines for detailed information on MRI safety and conditions. For commercial claims, please confirm device coding with payer prior to billing (see tables on pages six and seven). , lumbar, truncal, in a limb) via. . . Urgent Field Safety Notice . Device Record History (986dbdd5-8eeb-439c-ae82-92186b01bbc0) Close. ne. 251. Global Unique Device ID: 00813426020015. 1 Kapural L. 5’ Patient Contact Material Titanium, Silicone rubber, Epoxy Product Specifications Product Specification SheetSUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. de modèle : ACCK5xxx), une prise IPG (ACCK7000) et le générateur d'impulsions implantable Senza (n. Bring your patient ID card and Remote Control to the MRI appointment. products should be forwarded to: Nevro Corp. HFX spinal cord stimulation is approved for full-body MRI scans*, CT scans, and ultrasounds, allowing you to receive the care you need . Footnotes *Within conditional parameters. Check with the manufacturer for the most recent updates. 12-Month NSRBP RCT results published in the Journal of Neurosurgery: Spine. HFX relieves pain for nearly 80% of people, compared to only 49% who try a traditional spinal cord stimulator 1. Has anyone tried a device called HF10 ? It’s a device which stimulates your spinal cord to help relieve back and leg pain. During the procedure, one lead was placed without incident. . The contraindications associated with performing MRI on patients with an implanted Senza system include: - Do not use the transmit RF body coil for 1. MRI SAFETY INFORMATION The Axonics SNM System is an MR Conditional device. erfolgt unter Lizenz. Anesthesiology, 123(4) 2 Kapural L. 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. Os componentes implantados do sistema Senza podem incluir os elétrodos percutâneos (Modelo n. Typically safer than other spine surgeries used to address chronic pain 1-5. NEVRO CORP. MR Conditional . 00813426020572. comREDWOOD CITY, Calif. You canWe would like to show you a description here but the site won’t allow us. I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. 0 Tesla. Medtronic, Inc. 650. What is Nevro HFX? HFX is a nondrug, FDA-approved treatment option for long-term chronic pain relief. 187. , Redwood City, CA,. My pain management doctor has recommended it to me for. Was on opiates for 8 years until I attended & graduated from Mayo's 3-week Pain Rehab Program in 2018. 956. Applicant’s Name and Address: Nevro Corp. SENZA®, SENZA II® and Senza system. . 650. The HFX App was developed by Nevro to work with the HFX iQ™ Spinal Cord Stimulator. I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. Farrukh Ansari. u pacienta se systémem Nevro Senza SCS. MRI system type. Object Status. Magnetic Resonance Imaging (MRI) - The Senza system is MR. GENERAL INFORMATION Device Generic Name: Stimulator, Spinal-Cord, Totally Implanted for Pain Relief Device Trade Name: Senza® Spinal Cord Stimulation (SCS) System . the risk of severe injury or death. In the back of the booklet, we have added some information in the appendices. 1800 Bridge Parkway Redwood City, CA 94065 aus einem Senza®-Rückenmarkstimulationssystem und unterstützenden Dienstleistungen. 2. Please note that product literature varies by geography. o: LEAD2008-xxB), âncoras de elétrodos (Modelo n. 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. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today responded to Medtronic's announcement of FDA approval for painful diabetic neuropathy (PDN). Nevro Corp. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the SENZA®, SENZA II® & SENZA Omnia™ Systems. If the Senza system is right for you, your doctor will then implant the IPG. . 5 or 3. The device can deliver traditional spinal cord. The MRI clinician must consult the MRI guidelines for those conditions. Please note that the following components of the Senza system are . Keith Grossman Chairman, Chief Executive Officer and President *Senza HFX iQ™ uses a fixed set of instructions to provide optimized treatment recommendations that utilizeYes, with HFX you can safely have a full-body MRI scan. 1800 Bridge Parkway. Nevro touts 2-year data on senza spinal cord stimNevro hf10 therapy contact Nevro hf-10 trial video (real patient)Nevro senza spinal cord stimulator cleared in eu, australia for 3t mri. DRAFT 2. Product Code Description. Head Only MRI Systems. Refer to the Information for Prescribers (P/N 10001223) for indications, contraindications, warnings, warnings about other medical treatments, precautions,. Download. 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. S. Nevro® ACCK5300 GUDID 00813426020251 N300 Lead Anchor Kit NEVRO CORP. Also, please discuss the. Bench-top tests have shown that patients. 00813426020602. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025 USA Tel: +1. 9415 info@nevro. A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e. • The Senza system was the subject of the SENZA-RCT pivotal study, a ground-breaking study that was the first to. Safety Topic / Subject Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. Primary Device ID. Nevro Senza Spinal Cord Stimulation System Nevro Corporation, Strength 1. Nevro Corp. Do I Qualify? 1800 Bridge Parkway Redwood City, CA 94065. Bring your patient ID card and Remote Control to the MRI appointment. . The stimulation has been turned off and the patient is currently awaiting mri results and is under medical supervision. . The SENZA-RCT Randomized Controlled Trial. Nevro (NYSE: NVRO) said today that it won FDA approval for and launched its Senza Omnia spinal cord stimulation system. Object Status Conditional 5. Ihr HFX™ Gerät ist unter bestimmten Bedingungen für Ganzkörper-MRT-Untersuchungen zugelassen. Nevro aims to develop and publish rigorous evidence to support critical decisions made by physicians, regulators and payors. More . Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. (NYSE: NVRO ), a global medical deviceNevro, a company based in Menlo Park, California, won FDA approval for its Senza spinal cord stimulation system. HFX has a similar safety profile, including side effects and risks, to other. The Senza®, Senza II™ and Senza Omnia™ Senza is the First Implantable Spinal Cord Stimulator System that is 3 Tesla MRI Compatible Nevro Corp. Tel: +1. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back. . 1800 Bridge Parkway Redwood City, CA 94065 USA 1. Product Code Description HCPCS Code. HFX iQ is the only SCS system that uses Artificial. 12. 1800 Bridge Parkway Redwood City, CA 94065 U. 12-Month durability and crossover results published in Diabetes Care. Tel:. AccessGUDID - Nevro (00813426020510)- Senza II. The safety of HFX has been thoroughly studied and proven. THE List. Company Name: Nevro, Inc. Eseguire un esame MRIVectris™ SureScan® MRI 1x8 Subcompact Model 977A160, 977A175, 977A190;. MR Unsafe:More Frequency and Waveform Versatility. 17, 2018 /PRNewswire-AsiaNet/ - Nevro Corp. If you need support, please call: +1-844-331-1001. Safety Topic / Subject Neurostimulation. For United States of America only. Nevro SENZA®, SENZA II® and SENZA Omnia™ Spinal Cord Stimulation (SCS) implantable pulse generators (IPG) are MR Conditional devices that have been demonstrated to present no known hazards in a specified MR environment when following specific guidelines as described in this document. Estas instruções só se aplicam ao sistema Senza e não a outros produtos. 251. (NYSE: NVRO), a medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Senza spinal cord stimulation (SCS). Contraindications Associated with MRI with Senza System. 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 . Two crossed lines that form an 'X'. Primary Device ID: 00813426020015: NIH Device Record Key: cab471b0-af59-4957-8f6c-36c62219f5c0: Commercial Distribution Status: In Commercial DistributionAbout the SENZA-NSRBP RCT. October 7, 2021 ·. Scanning under diffe rent conditions may result in severe injury,Increase Patient Freedom. S. . Indicates the MRI Safety Information, if. November 5, 2019 By Sean Whooley. 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. All questions or concerns about Nevro Corp. 0005 . Please see the Patient Manual for important safety information and detailed MRI information. YOU ARE ABOUT TO EXIT FOR A WEBSITE INTENDED FOR THE RESIDENTS OF ANOTHER COUNTRY OR REGION. The Nevro Senza® HFX iQTM System TMand Senza® HFX Trial System work by delivering electrical energy from a stimulator to an area around the spine. Nevro's battery is designed to last 10+ years at all common programming settings. Brand Name: Senza®. Contraindications Please note that product literature varies by geography. , March 22, 2018 /PRNewswire/ -- Nevro Corp. HFX has a similar safety profile, including side effects and risks, to other. Senza, HF10, Nevro and the Nevro logo are. The physician hit the nerve root and the patient was in. all da. . g. . Despite technical challenges, MRI is feasible, safe and diagnostically useful in HF-SCS-implanted patients. . , mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for. 02789812-3f3c-4164-940d-291c85d741e5.