GENERAL INFORMATION Device Generic Name: Stimulator, Spinal-Cord, Totally Implanted for Pain Relief Device Trade Name: Senza® Spinal Cord Stimulation (SCS) System . * If you need more information about compatibility with MRI and CT scans, please contact your Nevro HFX Care Team at 1-888-895-8105. User Manual 11405 RevX Jason Smith Users Manual 01 Nevro Corporation PR1D3000 Patient Remote XKYPR1D3000 pr1d3000 PATIENT MANUAL Senza BLUETOOTH Trial System Effective May 2020 10000890 Rev 02 All questions or concerns about Nevro Corp. Includes an optional custom latex-free adhesive pouch. . Primary Device ID: 00813426020015: NIH Device Record Key: cab471b0-af59-4957-8f6c-36c62219f5c0: Commercial Distribution Status: In Commercial DistributionAbout the SENZA-NSRBP RCT. Check with the manufacturer for the most recent. Learn More. Results will be presented at the 2023 North American. . 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. HbA1C >10%. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. 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. Patient Manual 11052 Rev A (2015-01-15) [DRAFT] fINDICATIONS The Senza system is not right for everyone. . 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. 7. Senza HFX iQ is the first. Royal London Hospital for Integrated Medicine. NEVRO CORP. 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. . If you don’t have your patient ID card, please call your HFX Care Team for assistance. all da. These instructions only apply to the Senza system, and do not apply to other products. The safety of HFX has been thoroughly studied and proven. ‐ 1. 0005 Fax: +1. Safety Topic / Subject. Neurostimulation System. . S. Contraindications Senza is the First Implantable Spinal Cord Stimulator System that is 3 Tesla MRI Compatible Nevro Corp. com. The Omnia system is the first and only SCS system designed to deliver Nevro’s proprietary HF10 therapy in addition to all other available SCS frequencies. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. HFX relieves pain for nearly 80% of people, compared to only 49% who try a traditional spinal cord stimulator 1. . os: NIPG1000 ou NIPG1500) da Nevro. 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. Learn more about HFX iQ. . Indicates the MRI Safety Information, if. . ContraindicationsFull body conditional MRI labeling; Upgradable to future waveforms and frequencies; Omnia Clinician Programmer. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. NIH Device Record Key. The Senza and Senza II Systems are implantable systems and deliver stimulation using implantable leads. 4040 Campbell Avenue, Suite 210 Menlo Park, CA 94025 USA Tel: +1. Nevro Corp. 5, 3. Skin irritation may develop near the generator related to charging. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. Two crossed lines that form an 'X'. to protect your safety. The system is capable of delivering 10kHz therapy, a therapy that does not produce tingling sensations called paresthesia. We have now implanted in excess of 100 HF-SCS devices (Nevro Senza systems; Nevro Corp. 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. MRI Guidelines for Medtronic Neurostimulation Systems for Chronic Pain. Ability to provide or blend 2 distinct mechanisms of action. Paresthesia-Free with HF10®1,2 With HF10® programs (stimulation at 10,000 Hz), uniquely offered by Nevro, You will first use the Trial Stimulator and Remote Control. Nevro (n. ‐ Low SAR mode; SAR set based on device instructions. Version Model Number. Quick, outpatient & minimally invasive. Risks Associated with MRI with Senza System . What MRI safety information does the labeling contain?. **Throughout this presentation HFX TM for PDN means that a patient has been implanted with a Senza System and programmed to include a frequency of 10 kHz. 2 NEVRO CORP. Spectra WaveWriter Information for Prescribers Manual. 11095 Senza System 1. . In Commercial Distribution. NIH Device Record Key. 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. 5, 3. Safety Topic / Subject Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. . 12. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Pediatric Use – The safety and effectiveness of spinal cord stimulation has not been established for pediatric use. 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. de modèle : NIPG1000 ou NIPG1500). is under license. 251. AccessGUDID - Nevro® (00813426020251)- N300 Lead Anchor Kit. TM. . Please note that the following components of the Senza system are . See what other patients have to say as they give their Spinal Cord Stimulation Reviews on our YouTube channel. and any use of such marks by Nevro Corp. Download. 15, 2017 /PRNewswire/ -- Nevro Corp. 5T and 3T imaging. Paresthesia-Free with HF10®1,2 With HF10® programs (stimulation at 10,000 Hz),. 5. Tel: +1. 00813426020602. Nevro Corp. HFX iQ is the only SCS system that uses Artificial. 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. 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. 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. Magnetic Resonance Imaging Safety Status: MR CONDITIONAL: Indicates the MRI Safety Information, if any,. Patients used a Senza, Senza II, or Omnia device offering 10 kHz. The conditions for MRI scans will vary with the type of transmit. 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. 9415 info@nevro. 12-Month NSRBP RCT results published in the Journal of Neurosurgery: Spine. 650. Company Name: NEVRO CORP. Reported issues include infections, sepsis, shocking sensations, and numbness. o. 1 ASTM F2503-20, “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic ResonanceProduct 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. The system delivers SCS frequencies between 2Hz and 10,000Hz, along with the company’s HF10 therapy, which combines a 10kHz frequency. Sollten Sie Fragen oder Bedenken im Zusammenhang mit Produkten von Nevro haben, wenden Sie sich bitte anhand folgender Kontaktdaten an: Nevro Corp . Your device is therefore a restricted device. 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. Please note that the following components of the Senza system are . Nevro Corp. Nevro Corp. The 4. email, or text message communications about Nevro and other health information. 5. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of. Published May 8 2015. NEVRO CORP. . AccessGUDID - Nevro (00813426020510)- Senza II. Nevro Corp. Table of Contents INTRODUCTION. S. This afternoon. Conclusions. , lumbar, truncal, in a limb) via. You can We would like to show you a description here but the site won’t allow us. ContraindicationsSenza is the First Implantable Spinal Cord Stimulator System that is 3 Tesla MRI Compatible Nevro Corp. , paralysis). 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. MR Conditional . Tell the doctor who requested the MRI scan that you have an implanted spinal cord stimulation device 2. Jude/Abbott, and Stimwave have all developed SCS models that are labeled full body MRI conditional. This includes pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. MR Conditional . . 1. 5 T MRI and with 3. An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation. Company Name: NEVRO CORP. p: +1-650-251-0005. Patient position. Find a Doctor. Product Manuals for Healthcare Professionals. . S. The Senza neuromodulation system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. Labeling does not contain MRI Safety Information Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801. Spinal Cord Neurostimulator. It is important to read this full document prior to conducting or recommending an MRI examination on a patient with the Senza system. ContraindicationsA comprehensive, authoritative textbook on MRI health & safety concerns with contributions from more than fifty internationally respected experts in the field. Safety Topic / Subject Neurostimulation. 11095 Senza System 1. 956. 650. (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 expanded MR-conditional labeling. Jude Medical. Kapural L, et al. . M939858A010 Rev C 1. IMPORTANT: Do not change or modify any component of the Senza ® TMHFX iQ. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. A. q4cdn. It is is the first. Intuitive functionality to enhance the patient experience and improve ease. Please see the Patient Manual for important safety information and detailed MRI information. 1800 Bridge Parkway Redwood City, CA 94065 U. Head Only MRI Systems. Nevro® SENZA®, SENZA II® and SENZA Omnia™ Spinal Cord Stimulation (SCS) implantable pulse generators (IPG) are MR Conditional devices that have been. S. 2015;123(4):851-60. Bühne frei für Senza. 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. 5 T and 3 T) experience and safety profile in a large. . 251. 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for Senza® HFX iQTM System. Your MRI Tech will confirm the results before your MRI. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. This includes pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. 17, 2018 /PRNewswire-AsiaNet/ - Nevro Corp. For thiswe thank you for your continued support of Nevro. 9415 [email protected] MDSS GMBH Schiffgraben 41 D-30175 Hannover, Germany Australian. 12. 3 . 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. Nevro HFX TM Guide Email or print this guide now and bring it to your next appointment. 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. Nevro Corp. UW Health Radiology Guidelines for MRI in Patients with Common Complex Devices:. If the Senza system is right for you, your doctor will then implant the IPG. 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. This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. This booklet was written for people who are considering or have received a Nevro® Senza® Spinal Cord Stimulator (SCS) system to help treat pain. Object Status. For United States of America only. This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility managers, and others. 15, 2017 /PRNewswire/ - Nevro Corp. Budet. An electrode: this sits in the epidural space and delivers very small and precise currents. g. (3T has severe limitations. Risks Associated with MRI with Senza System . Objectives. report ›Brand Name: Nevro Version or Model: ACCK7200 Commercial Distribution Status: In Commercial Distribution Catalog Number: ACCK7200 Company Name: NEVRO. For commercial claims, please confirm device coding with payer prior to billing (see tables on pages six and seven). 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. RestoreAdvanced SureScan MRI, Model 97713. 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's SENZA-PDN study, the largest randomized clinical trial (RCT) of spinal cord stimulation treatment conducted thus far, compares HF10 therapy plus Conventional Medical Management (CMM) to. . 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. The safety of HFX has been thoroughly studied and proven. Noter que les éléments MR Conditional du système Senza . 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. Jude Medical More. : +1. Indications, Safety, and Warnings. All frequencies between 2-1,200 Hz and 10,000 Hz. S. The Senza SCS System is shown in Figure 1 below:AccessGUDID - Senza® (00813426020121)- Senza® Charger Kit . 9415 info@nevrocorp. Please reference the “Impedance Check Instructions” section in this booklet. Nevro Senza Spinal Cord Stimulator ‐ MRI available Mon‐Fri, 8am‐5pm; Univ Hospital Only. . 1 ASTM F2503-20, „Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment“ (Standardpraxis zur Kennzeichnung von Medizinprodukten und sonstigen Gegenständen. to protect your safety. Physician Implant Manual 11051 Rev D. Nevro Corp. The company provides solutions for the treatment of chronic pain. Contraindications have questions about whether the Senza system may be right for you, ask your doctor. 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. 5 T MRI and 3. It is important to read the entire SENZA System MRI Guidelines manual (11096) prior to conducting an MRI scan. 1800 Bridge Parkway Redwood City, CA 94065, USA Tel: +1. . Nevro Senza Spinal Cord Stimulator - MRI available. Nevro, SENZA, SENZA II, Omnia, SENZA Omnia, Senza Bluetooth®, Surpass, Surpass-C, HF10 und das Nevro-Logo. 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 Corp. Comparison of Spinal Cord Stimulators from Boston Sci. . S. 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. If you don’t have your patient ID card, please call your HFX Care Team for assistance. Pediatric Use - The safety and effectiveness of spinal cord stimulation has not been established for use in children. April 30th, 2021 . , lumbar, truncal, in a limb) via. Version (Model) Number: NIPG2500. , March 22, 2018 /PRNewswire/ -- Nevro Corp. The contraindications associated with performing MRI on patients with an implanted Senza system include: - Do not use the transmit RF body coil for 1. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). Nevro (NYSE: NVRO ) said yesterday that the FDA approved MRI-conditional labeling for its Senza spinal cord stimulation system designed to deliver HF10 therapy. 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. 650. g. All questions or concerns about Nevro Corp. Product Code Description. Worldwide, tens of thousands of patients are enjoying more freedom and improvement in their daily lives with Nevro products. Medtronic Prima Advanced Surescan MRI: 2013: Nevro Senza: 2015: Nevro Senza II: 2018: Open in a separate window. First, any new SCS technology would need to be formally evaluated in clinical trials for both safety and effectiveness prior to commercialization. e-li mít dotazy, kontaktujte prosím společnost Nevro na adrese nebo telefonním čísle, které jsou uvedeny na konci tohoto dokumentu. MRI uses a powerful static magnetic field, gradient magnetic fields, and RF energy to construct an image of a section of the body. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. Device Procode: LGW . g. 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 . 15, 2017 /PRNewswire/ - Nevro Corp. Global Unique Device ID: 00813426020572. Any serious incident that occurs in relation to the device should be forwarded to Nevro Corp. 5. Please note that product literature varies by geography. Typically safer than other spine surgeries used to address chronic pain 1-5. Risks Associated with MRI with SENZA System . Risks Associated with MRI with Senza System . inside the body (see IPG in the diagram above). ). Nevro (NYSE:NVRO) said yesterday that the FDA approved MRI-conditional labeling for its Senza spinal cord stimulation system designed to deliver HF10 therapy. Device Record History (986dbdd5-8eeb-439c-ae82-92186b01bbc0) Close. . The MRI clinician must consult the MRI guidelines for those conditions. Bench-top tests have shown that patients. Upgradable to future waveforms and. com . Krishnan Chakravarthy serves as a consultant to Abbott, Medtronic, Bioness, SPR Therapeutics, Nalu Medical, Omnia Medical, and Saluda Medical; founder of Newrom. ) ‐ Required Nevro Rep (device programming) ‐AND‐ MRI Physicist (Low SAR settings). 650. FDA. , March 22, 2018 /PRNewswire/ -- Nevro Corp. For United States of America. Commercial Distribution Status: In Commercial Distribution. 1 ABOUT CHRONIC PAINYOU ARE ABOUT TO EXIT FOR A WEBSITE INTENDED FOR THE RESIDENTS OF ANOTHER COUNTRY OR REGION. However, MRI safety recommendations continue to vary significantly between SCS models and companies (12-16). 650. S. Refer to the Information for Prescribers (P/N 10001223) for indications, contraindications, warnings, warnings about other medical treatments, precautions,. Nevro has developed and commercialized the Senza. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. Senza Summary of Safety and Effectiveness Data (SSED). It is based on common questions that patients have about their condition, this particular treatment option, and the Senza system. , Mount Olive, NJ, USA) has discussed in reference to the risk of accidental infusion of drug which could result in patient injury or death. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. . 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. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. “Now I have an active lifestyle for the first time since I was in my 30s. Medtronic, Inc. I've lived with severe chronic pain in my legs and lumbar spine for the past ten years. 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. 3876 Nevro. Please see the Patient Manual for important safety information and detailed MRI information. , lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to. 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. Effective November 2022. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that 24-month data from the SENZA Painful Diabetic Neuropathy (PDN) Randomized Controlled Trial (RCT), the largest RCT to evaluate spinal cord stimulation. Easily pair the widest array of waveform types, including paresthesia-based. 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. Device Procode: LGW . More . Device Name: Senza® IPG Kit. S. g. de modèle : LEAD2008-xxB), des ancrages d'électrode (n. (NYSE: NVRO ), a global medical deviceNevro, a company based in Menlo Park, California, won FDA approval for its Senza spinal cord stimulation system. [email protected] INSTRUCTIONS FOR USE AT ALL TIMES. Primary Device ID. Nevro Corp. Bring your patient ID card and Remote Control to the MRI appointment. FCC CFR 47 Part 15. 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. What MRI safety information does the labeling contain? MR Unsafe Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801. c488b2ec-7692-41e0-9d08-7f6942b94fbb. . Data from last assessment, average 17. 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. conditions. Nevro recommends reviewing commercial contracts and medical policies to determine if it is appropriate to bill certain HCPCS codes described herein. Medgadget nevroStimulator spinal fda cleared eisner fri Nevro hf10 breakthrough chronic minimally invasive addictive 3tvNevro (hf10 therapy). AccessGUDID - Nevro® (00813426020398)- Surgical Lead Kit, 50cm. p: +1-650-251-0005 Australian Contact Number: 02 8091 2878Side effects or risks involved with the Senza System: Important Safety Information 10 kHz Therapy and other available SCS frequencies and waveforms are delivered by Senza Spinal Cord Stimulation (SCS) systems. 251. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. . Precision Montage™ MRI SCS System. Nevro aims to develop and publish rigorous evidence to support critical decisions made by physicians, regulators and payors. 1. FCC CFR 47 Part 15. Version (Model) Number: NIPG1500. S. Safety Topic / Subject. Primary Device ID. os. 5’ Patient Contact Material Titanium, Silicone rubber, Epoxy Product Specifications Product Specification SheetSUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) I. . . 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.