Version (Model) Number: NIPG2000. Physician Implant Manual 11051 Rev D. Commercial Distribution Status: In Commercial Distribution. FOLLOW THE INSTRUCTIONS FOR USE IF SYMPTOMS PERSIST SEE YOUR DOCTOR/HEALTHCARE PROFESSIONAL. Senza HFX iQ is the first. Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801. (NYSE: BSX) announced today that they have reached a settlement in their ongoing intellectual property litigations that gives Boston Scientific the freedom to operate using the features and capabilities embodied in its current line of products for frequencies below 1,500 Hz, and. In the US, our SCS systems are now approved to deliver all available SCS frequencies and the most waveform types in a single product, helping people living with chronic pain. 650. . It is important to read this full document prior to conducting or recommending an MRI examination on a patient with the Senza system. 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. 5T Highly Preferred. The safety of HFX has been thoroughly studied and proven. Spectra WaveWriter Information for Prescribers Manual. Includes an optional custom latex-free adhesive pouch. See what other patients have to say as they give their Spinal Cord Stimulation Reviews on our YouTube channel. 2 NEVRO CORP. Nevro Corp. 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. , lumbar, truncal, in a limb) via. Before your MRI scan, be sure to charge your IPG and make sure your stimulation is switched to OFF. Other Active Implanted Devices – The Senza, Senza II, and Senza Omnia Systems may interfere with otherSenza® HFX iQ™ IPG Nevro Corp. My pain management doctor has recommended it to me for. S. 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. 5 Risks Associated with MRI with Senza System. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. NEVRO CORP. Nevro Corp. 650. Commercial Distribution Status. ARTEN600090483 AMENLO PARK, Calif. o. The stimulation has been turned off and the patient is currently awaiting mri results and is under medical supervision. Nevro. Brand Name: Nevro. 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. Nevro Corp. 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. National Hospital for Neurology and Neurosurgery. c488b2ec-7692-41e0-9d08-7f6942b94fbb. . First, any new SCS technology would need to be formally evaluated in clinical trials for both safety and effectiveness prior to commercialization. Version (Model) Number: NIPG1500. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ≥65% of patients across six peer-reviewed clinical studies. MR Conditional . Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System, Neuromodulation System. . Class action. 5, 3. 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 . . Pediatric Use - The safety and effectiveness of spinal cord stimulation has not been established for use in children. Furthermore, it is not intended to increase or maximize reimbursement by any payer. Safety Topic / Subject Neurostimulation. 12. 5-T and 3-T. Nevro aims to develop and publish rigorous evidence to support critical decisions made by physicians, regulators and payors. It indicates a way to close an interaction, or dismiss a notification. Nevro recommends reviewing commercial contracts and medical policies to determine if it is appropriate to bill certain HCPCS codes described herein. 2 NEVRO CORP. Risks Associated with MRI with Senza System . The table below contains the HCPCS Level II codes, as well as the L-codes, that might be listed in a medical policy or commercial contract. The primary endpoint of the study is a composite endpoint that includes the difference in proportion of treatment responders without. Minimal restrictions and reversible. 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. Full-Body MRI Conditional Labeling Now Available in United States for Nevro Senza® Spinal Cord Stimulation System 3/22/2018 Expanding Patient Access to Nevro's HF10® Therapy Through Broader Imaging Compatibility REDWOOD CITY, Calif. Safety Topic / Subject Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. The system delivers SCS frequencies between 2Hz and 10,000Hz, along with the company’s HF10 therapy, which combines a 10kHz frequency. . By the early 1960s, scleral buckling became the method of choice when the development of new. . 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. Version (Model) Number: NIPG2500. Nevro Headquarters. conditions. products should be forwarded to: Nevro Corp. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. The device can deliver traditional spinal cord. Article Text. Please see the Patient Manual for important safety information and detailed MRI information. , graphical user interface), integrated software, and a wireless communication transmitter and receiver. Some spinal cord stimulators are safe for an MRI, but others aren’t. HFX has a similar safety profile, including side effects and risks, to other. 1800 Bridge Parkway Redwood City, CA 94065 U. Refer to Senza MRI Guidelines for detailed information on MRI safety and conditions. This afternoon. NSRBP RCT. Risks Associated with MRI with Senza System . g. Refer to the Information for Prescribers (P/N 10001223) for indications, contraindications, warnings, warnings about other medical treatments, precautions,. Please check with your payer or Nevro’s Health. Brand Name. MENLO PARK, Calif. * Some other rechargeable systems are not approved for full body MRI scans. During the trial of the Senza System, a thin flexible wire (stimulator lead) is typically placed through a needle. News provided by. Keith. g. The evolution of neuromodulation devices in order to enter magnetic resonance imaging (MRI) scanners has been one of understanding limitations, engineering modifications, and the development of a consensus within the community in which the FDA could safely administer labeling for the devices. Intuitive functionality to enhance the patient experience and improve ease. It is based on common questions that patients have about their condition, this particular treatment option, and the Senza system. is under license. Bench-top tests have shown that patients. Medicare accepts the below C-codes. . 7. Download. For commercial claims, please confirm device coding with payer prior to billing (see tables on pages six and seven). *HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment of chronic pain. Tell the doctor who requested the MRI scan that you have an implanted spinal cord stimulation device 2. PATENT NUMBER ISSUE DATE TITLE; CN ZL201780019179. 650. It is is the first. The Senza SCS System is shown in Figure 1 below:AccessGUDID - Senza® (00813426020121)- Senza® Charger Kit . 11096 Rev J MRI Procedure Information For Abbott Medical MR Conditional Neurostimulation Systems. com MDSS GMBH Schiffgraben 41 D-30175 Hannover, Germany Australian. . com CLOSE. . Nevro Corp. Only use 1. The Senza®, Senza II™and Senza Omnia™neuromodulation systems, whenIntroduction. Spectra WaveWriter™ SCS System. 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. Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801. 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. All questions…There are at least 500 FDA consumer complaints over the last five years following a Nevro Senza device implant. In fact, approximately 82% of patients with an implanted spinal cord stimulation system (SCS) are expected to need at least one MRI within five years1 of implant. * If you need more information about compatibility with MRI and CT scans, please contact your Nevro HFX Care Team at 1-888-895-8105. . 1. Nevro patient satisfaction. I've lived with severe chronic pain in my legs and lumbar spine for the past ten years. 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. Strong interference, such as from a defibrillator or MRI (if the spinal cord stimulation device is not MRI-safe), can damage the generator, leading to severe burns, other serious injury, or death. Minimal restrictions and reversible. Patient Manual 11052 Rev A (2015-01-15) [DRAFT] fINDICATIONS The Senza system is not right for everyone. Version Model Number. to protect your device. Email: info@nevro. Jude Medical More. HF10 therapy. 2. Risks Associated with MRI with Senza System. 0 T MRI, as both were used to identify nine tumours, metastatic infiltration in 16 patients, and fibre thickening in two patients (nerve tumours and brachial. 6. 251. Spinal Cord Stimulation (SCS) System: Abbott and St. During the procedure, one lead was placed without incident. Stellen Sie folgende Punkte sicher, falls ein Arzt eine MRT-Untersuchung bei Ihnen anordnet: 1. Learn more about HFX iQ. 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. The IPG is implanted in a subcutaneous pocket. . The physician hit the nerve root and the patient was in. In Commercial Distribution. e. %PDF-1. 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. - Many. 5 T MRI and 3. Published May 8 2015. Omnia. We’re here to help you. HbA1C >10%. 5 T MRI and 3. Spinal Cord Neurostimulator. 5. com. Full Body MRI7 All Nevro systems are conditionally approved for full body MRI scans. FCC CFR 47 Part 15. Novel 10-kHz High-frequency Therapy Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain. 15, 2017 /PRNewswire/ - Nevro Corp. – The safety of program settings above 1,200 Hz have not been studied above the T8 vertebral level. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG2000: Device Problem Adverse Event Without Identified Device or Use Problem (2993). 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). . (MRI) - The Senza system is MR Conditional which . DRAFT Physician Implant Manual SenzaÂŽ Senza IIâ ˘ ONLY NEVRO CORP. 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. Risks Associated with MRI with Senza System . 7 million in Q1 2015, up 70% at constant currencies. 2 attorney answers. Contraindicationshave questions about whether the Senza system may be right for you, ask your doctor. . Bring your patient ID card and Remote Control to the MRI appointment. [email protected] INSTRUCTIONS FOR USE AT ALL TIMES. MRI COMPATIBILITY. At the time of your procedure, your doctor will provide your specific recovery instructions and it’s important to follow them closely. Tel: +1. Nevro pursues clinical research to better support healthcare providers in treating chronic pain. 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 . 00813426020602. The system won FDA approval in November 2019. Our SCS systems are now approved to deliver 2. Full body conditional MRI labeling; Upgradable to future waveforms and frequencies; Omnia Clinician Programmer. IMPORTANT: Do not change or modify any component of the Senza ® TMHFX iQ System and Senza ®. Jude Medical. Please see the Patient Manual for important safety information and detailed MRI information. Bench-top tests have shown that patients implanted with the Senza system can be safely exposed to MR environments specified in this guideline. . • Non eseguire un esame MRI se gli elettrocateteri non sono collegati all'IPG o agli adattatori. Company Name: NEVRO CORP. IMPORTANT: Do not change or modify any component of the Senza ® HFX iQ. – BY UW MRI SAFETY COMMITTEE APPROVED GUID ELINES - MRI available Monday -Friday, 8am-5pm; University Hospital Only. to protect your device. Risks Associated with MRI with Senza System . Nevro recommends that patients implanted with Surpass surgical leads undergo MRI examination per the guidelines provided in 1. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. You will first use the Trial Stimulator and Remote Control. “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. Nevro IPG(s) NIPG1000, NIPG1500, NIPG2000, NIPG2500 Nevro Percutaneous Leads LEAD10x8-xxB: LEAD1058-50B,. S. Urgent Field Safety Notice . Ask a lawyer - it's free! Browse related questions. Se tiver perguntas, contacte a Nevro através da morada ou do número de telefone indicados no fim deste documento. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. . Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. SENZA®, SENZA II® and Senza system. 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. It includes an implanted lead/electrode system located in the epidural space of the spinal cord attached to either an implanted passive electronic circuit into which signals and/or energy is inductively coupled from outside the body, or to a. Results will be presented at the 2023 North American. SENZA NEVRO SENZA: Back to Search Results: Model Number LEAD1058-70B: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930) Event Date 11/04/2019: Event Type Injury Manufacturer Narrative. The 4. , Nevro. 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. 0 T MRI (30 of 30 found with both technologies), and clinical diagnoses were the same for 1. report ›Brand Name: Nevro Version or Model: ACCK7200 Commercial Distribution Status: In Commercial Distribution Catalog Number: ACCK7200 Company Name: NEVRO. g. Some key features include: turn stim on/off, check battery, turn on MRI mode. , et al. Conclusions. q4cdn. and any use of such marks by Nevro Corp. AccessGUDID - Nevro (00813426020510)- Senza II. 437):An mri with an implanted device, it is important to read, understand, and comply with these instructions to prevent potential harm to the patient and/or dam age to the device. 2. 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. 1 ABOUT CHRONIC PAINYOU ARE ABOUT TO EXIT FOR A WEBSITE INTENDED FOR THE RESIDENTS OF ANOTHER COUNTRY OR REGION. 5T cylindrical-bore magnet, horizontal field orientation MRI systems. Contraindications An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). Event. Version (Model) Number: NIPG2500. g. Version or Model: NIPG1500. 00813426020572. 1800 Bridge Parkway . 0005 Fax: +1. WARNINGS Warnings are statements about safety of your device that you should take very seriously. Please note that product literature varies by geography. AccessGUDID - Nevro (00813426020510)- Senza II. Contraindications Full body conditional MRI labeling; Upgradable to future waveforms and frequencies; Omnia Clinician Programmer. Axonics MRI Patient Guidelines – United States 2 3. This is just one spinal cord stimulation review on the Nevro SCS system specifically. ‐ Low SAR mode; SAR set based on device instructions. Medtronic Prima Advanced Surescan MRI: 2013: Nevro Senza: 2015: Nevro Senza II: 2018: Open in a separate window. email, or text message communications about Nevro and other health information. • Fail to receive effective pain relief during trial stimulation. 0 T MRI, as both were used to identify nine tumours, metastatic infiltration in 16 patients, and fibre thickening in two patients (nerve tumours and brachial. Product Code Description. Click to view and download the complete guide now!. 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. I've lived with severe chronic pain in my legs and lumbar spine for the past ten years. 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. Also, please discuss the. Object Category Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporatio. Device Name: Senza II. the risk of severe injury or death. 1800 Bridge Parkway Redwood City, CA 94065, USA. 5T and 3T imaging. 251. Nevro Corp. Nevro Headquarters. o: LEAD2008-xxB), âncoras de elétrodos (Modelo n. . , Redwood City, CA,. 1800 Bridge Parkway Redwood City, CA 94065 U. Please note that the following components of the Senza system are . Nevro Corp. Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801. Please reference the “Impedance Check Instructions” section in this booklet. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for Senza® HFX iQTM System. Nevro, SENZA, SENZA II, Omnia, SENZA Omnia, Senza Bluetooth®, Surpass, Surpass-C, HF10 und das Nevro-Logo. Device Name: Senza Omnia IPG Kit . This means that patients with the Axonics SNM System can safely have MRI examinations of any body part under certain conditions. S. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. “Now I have an active lifestyle for the first time since I was in my 30s. , lumbar, truncal, in a limb) via. All questions or concerns about Nevro Corp. Medical technologies are continually changing and magnetic resonance imaging (MRI) is no exception, where increasing the magnet strength has produced more sophisticated device capabilities. What MRI safety information does the labeling contain?. – The safety of program settings above 1,200 Hz have not been studied above the T8 vertebral level. 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 . Every person is unique and your medical needs differ from those of others, even people with the same. Please note that the following components of the Senza system are . Spinal cord stimulator restrictions have three goals: 1. 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. 12. Nevro Corp. On the back of the commercialization of Senza in the European Union and Australia, achieved over the past 5 years, Nevro reported revenues of $9. Senza MRI Guidelines; Senza Summary of Safety and Effectiveness Data (SSED). Upgradable to future waveforms and. 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 []. Brand Name: Nevro® Version or Model: ACCK3050 Commercial Distribution Status: In Commercial Distribution Catalog Number: ACCK3050 Company Name: NEVRO. Nevro's battery is designed to last 10+ years at all common programming settings. de modèle : NIPG1000 ou NIPG1500). ne. In the back of the booklet, we have added some information in the appendices. (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. (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. Brand Name. . UW Health Radiology Guidelines for MRI in Patients with Common Complex Devices:. 9415 [email protected] MDSS GMBH Schiffgraben 41 D-30175 Hannover, Germany Australian. Use only product literature from the region where the patient procedure was performed. The second part of this booklet explains how to use the devices. The SENZA-RCT Randomized Controlled Trial. Programmers will display one of the icons below to indicate MRI eligibility based on the patient’s SCS system. Senza, HF10, Nevro and the Nevro logo are. Global Unique Device ID: 00813426020015. . MR Conditional . Kapural L, et al. . ContraindicationsA comprehensive, authoritative textbook on MRI health & safety concerns with contributions from more than fifty internationally respected experts in the field. Model(s): SC-1200; MRI Full Body Patient Eligibility Checklist . Check with the manufacturer for the most recent updates. 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. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. S. . inside the body (see IPG in the diagram above). 12-Month durability and crossover results published in Diabetes Care. The US Food and Drug Administration has approved the next-generation Senza II Spinal Cord Stimulation (SCS) System (Nevro) delivering HF10 therapy. Device Name: Senza Omnia IPG Kit . Conclusion. . TM. Company Name: NEVRO CORP. NEVRO CORP. Please note that product literature varies by geography. (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. Nevro Hf10 Mri Guidelines. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: 24-month. NIH Device Record Key. An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation. TM. Refer to Senza MRI Guidelines for detailed information on MRI safety and conditions. Product Name: Senza Spinal Cord Stimulation (SCS) System PMA Applicant: Nevro Corporation Address: 1800 Bridge Parkway Redwood City, CA 94065 Approval Date: January 18, 2022 Approval Letter. Nevro Corporation, Risks Associated with MRI with Senza System . TM. The physician had difficulty placing the lead due to scar tissue. 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. . Patient position. Before your MRI scan, be sure to charge your IPG and make sure your stimulation is switched to OFF. Dies ermöglicht Ihnen, Ihren Patienten die breiteste Palette an Stimulationsformen anzubieten - heute und in Zukunft. What is Nevro HFX? HFX is a nondrug, FDA-approved treatment option for long-term chronic pain relief. . Device Procode: LGW . full market launch of its HFX iQ spinal cord stimulation (SCS) system, following the completion of a successful limited market. 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. 437):MRI In the past decade, Boston Scientific, Medtronic, Nevro, St. . 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. s28. 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. Risks Associated with MRI with Senza System . The Senza delivers Nevro’s proprietary HF10 therapy to help control chronic pain. If you don’t have your patient ID card, please call your HFX Care Team for assistance. 251. 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 . 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. The Redwood City, Calif. This application allows patients to input their daily pain, medication use and activity levels to provide a personalized therapy recommendation using Bluetooth® wireless technology. Source: The implanted senza spinal cord stimulation (scs) system (nevro corporation) is mr conditional and has been demonstrated. Anesthesiology. 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. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. • 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. Conditional 5 More. . NEVRO CORP. Product Manuals for Healthcare Professionals.