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Medtronic, Inc. (“Medtronic”) offers RemoteView, which permits a user (“Programmer User”) of the Medtronic CareLink® 2090 Programmer (“Programmer”) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (“Remote Viewer”), including remote health care professionals or Medtronic representatives.
Limited License Grant. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. You shall have sole responsibility for any fees or charges, including service or data charges, incurred by you in connection with your use of the Licensed Software. You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation.
Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
“Active Remote Viewer” as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software.
By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User:
) Registration. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. All information that you provide in connection with such registration must be complete, accurate, and truthful. The user name and password are personal to you and must not be shared with anyone else. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password.
) Your Personal Information. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. You agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America.
) Session Key. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. “Session Key” as used herein means a unique token active for a limited period of time generated by the Remote Viewer. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session.
) Logging of Session Activity. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America.
) Active Remote Users. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information.
) Availability. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time.
Permissions. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software.
Your Acknowledgements. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patient’s implanted cardiac device data, including any data on the Programmer. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients.
Security/Privacy of Patient Data. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information.
Reporting Issues and Feedback. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. If you submit any comments or ideas to Medtronic, in the absence of a separate agreement regarding such submissions, you grant to Medtronic an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such ideas in any medium and agree that Medtronic is free to use them for any purpose. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Any maintenance and support services provided by Medtronic shall be at Medtronic’s sole discretion.
Limitations of Liability.
THE LICENSED SOFTWARE IS PROVIDED TO YOU “AS IS,” AND MEDTRONIC EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE AND YOUR USE THEREOF, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE.
Legal Compliance. You shall at all times use the Licensed Software in compliance with all applicable laws. You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a “terrorist supporting” country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties.
Term, Termination, Modifications, and Support. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Medtronic may modify, amend, or terminate this Agreement at any time, including by providing notices or an updated version of this Agreement on a Medtronic website. Medtronic may modify, disable, or terminate your use or Medtronic’s support of the Licensed Software at any time, including by providing notices on a Medtronic website. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. At any time upon Medtronic’s request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. In addition, upon Medtronic’s request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction.
NayaMed International Sárl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Sárl. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses.
This describes the alignment of the skeletal system in the sagittal plane. Both the global and regional levels of sagittal alignment should be considered:
It is also important to recognize the difference between sagittal alignment and sagittal balance:
Alignment of the skeletal system in the sagittal plane can be affected by several factors, including pelvic anatomy, body mass, degeneration, instability, deformity, and previous surgeries. Normal alignment is patient-specific.
Sagittal alignment of the spine may be restored through increasing segmental lordosis. In OLIF procedures, a large lordotic cage is placed on the vertebral apophysis, which is the strongest part of vertebral body, minimizing the risk of graft subsidence.
Sagittal malalignment can cause abnormal posture and motion, including loss of horizontal gaze, center of gravity away from feet, loss of capacity to react to disturbances in balance, and increased energy expenditure leading to fatigue, disability, and pain. To compensate for the malalignment and restore horizontal gaze, patients often tilt their pelvis forward (increasing pelvic tilt) and flex their knees.
Pelvic incidence (PI) is the +angle between the perpendicular line to the sacral plate at its midpoint and the line connecting this point to the biocoxofemoeral axis. It is a patient- specific, anatomical parameter related to the shape of the pelvis and is fixed from skeletal maturity. PI value is constant1 and not affected by patient position or age after maturity. It is typically about 40° to 60°.2,3
Pelvic tilt (PT) is "defined by the angle between the vertical line through the midpoint of the sacral plate" and the line connecting this point to biocoxofemoeral axis. It is a positional parameter representing the position of the pelvis relative to a vertical reference. PT value varies depending on the extent of pelvic retroversion (compensation) and is typically 5° to 20°.2,3
Sacral slope (SS) is the angle of the sacral plate in relation to horizontal line. It is a positional parameter indicating the slope of the sacral endplate (base of the spine) relative to a horizontal reference. The value of SS varies, changing inversely with pelvic tilt and is typically 30° to 50°.2,3
Spinopelvic mismatch (PI-LL mismatch) provides an indicator for a patient’s optimal lumbar curvature and can be measured from standard lateral lumbar films including femoral heads. Sagittal alignment is considered optimum when spino-pelvic mismatch (PI-LL) is less than 9° (LL= PI +-9°).3,4
Pelvic Tilt (PT) is a spinopelvic parameter that represents the relationship of the femoral heads to the sacrum in sagittal plane. A spinal realignment surgery should aim to achieve PT of less than 20°.4
Sagittal vertical axis (SVA) is measured as the distance between the C7 plumb line and the posterior-superior corner of S15,6 and is optimum when less than 5 cm (SVA < 5 cm).5,6 SVA is commonly used to assess deformity. A 36" x-ray of the full thoracolumbar spine is used to measure SVA.
Both T1-Spinopelvic Incidence (T1-SPI) and SVA represent the truncal inclination in reference to the pelvis. Global spinal realignment should aim to achieve T1-SPA of less than 0° and SVA less than 50 mm.4
In this retrospective study, n=48 patients with a L4-L5 fusion and minimum year follow-up (mean follow-up of 44.6 months) were evaluated and divided into two groups based on the development of adjacent segment disease (ASD, as defined by radiographic criteria) at final follow-up. 62.5% (30/48) of patients were in Group 1 (developed ASD), and n=18 patients were in Group 2 (no ASD).
There were no statistically significant differences in sex, weight, original diagnosis, bone mineral density, preoperative segmental lordosis, preoperative lumbar lordosis (LL), and preoperative clinical outcome score between the groups. There was a significant difference in LL improvement between the groups (-5.8° in Group 1 vs. 0.6° in Group 2, p=0.0228). Patients who developed ASD had decreased LL postoperatively.
In this retrospective cohort study, the MRI scans of n=90 subjects without spine surgery were analyzed at two different time intervals for the presence or absence of disc degeneration (DD) using the Pfirrmann grade classification.
The two MRIs had a minimum of four year intervals. 38% (34/90) of subjects had no DD progression compared to 62% (56/90) with DD progression. Subjects with no DD progression had a significantly higher lumbar lordosis than subjects with DD (49°vs. 43°, p=0.017). Authors concluded that lumbar hypolordosis could be predictive of progression of degenerative changes in the disc.
In this retrospective study, the radiographic parameters of n=45 patients with symptomatic adjacent segment disease (ASD) that required surgery were compared to n=39 matched controls who had no signs of symptomatic ASD upon last follow-up (mean follow-up of 84 months and minimum of five year follow-up).
Controls had similar preoperative grades of disc degeneration on MRI. The pelvic incidence (PI) and pelvic tilt (PT) were significantly higher in the ASD group (PI: 60.9° vs. 51.7°, p=0.001 and PT: 22.4° vs. 18.8°, p=0.012). The lumbar lordosis was significantly lower in the ASD group (48.1° vs. 53.8°, p=0.012).
Barrey C, Jund J, Noseda O, Roussouly P (2007) Sagittal balance of the pelvis-spine complex and lumbar degenerative diseases. A comparative study about 85 cases. Eur Spin J 16 (9): 1459-67.
Vaz G, Roussouly P, Berthonnaud E., Dimnet J (2002) Sagittal morphology and equilibrium of pelvis and spine. Eur Spine J 1(11):80- 87.
Schwab F, Lafage V, Patel A, Farcy JP (2009) Sagittal plane considerations and the pelvis in the adult patient. Spine 34 (17): 1828-33.
Schwab F, Patel A, Ungar B, Farcy JP, Lafage V (2010) Adult spinal deformity-postoperative standing imbalance: how much can you tolerate? An overview of key parameters in assessing alignment and planning corrective surgery. Spine 35 (25):2224-31.
Jackson RP, McManus AC (1994). Radiographic analysis of sagittal plane alignment and balance in standing volunteers and patients with low back pain matched for age, sex, and size: a prospective controlled clinical study. Spine 19:1611-8.
Gelb D, Lenke L, Bridwell K, Blanke K, McEnery K (1995). An analysis of sagittal spinal alignment in 100 asymptomatic middle and older aged volunteers. Spine 20 (12): 1351-8.
Min, J. H., Jang, J. S., Jung, B., Lee, H. Y., Choi, W. C., Shim, C. S., Lee, S. H. The clinical characteristics and risk factors for the adjacent segment degeneration in instrumented lumbar fusion. J Spinal Disord Tech, 2008. 21(5): p. 305-9.
Farshad-Amacker, N. A., Hughes, A. P., Aichmair, A., Herzog, R. J., Farshad, M. Determinants of evolution of endplate and disc degeneration in the lumbar spine: a multifactorial perspective. Eur Spine J, 2014. 23(9): p. 1863-8.
Rothenfluh, D. A., Mueller, D. A., Rothenfluh, E., & Min, K. Pelvic incidence-lumbar lordosis mismatch predisposes to adjacent segment disease after lumbar spinal fusion. Eur Spine J, 2014. (Epub)
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