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27 Executive Briefing Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. The report was double-blinded and doesn't mitigate that the panel process has subjective input. However, it can be noted that strict adherence by the multidisciplinary experts to adopt the RAND™ methodology process based on published clinical evidence and expertise was observed. How you treat vertebral compression fractures can impact burden to the healthcare system The care pathway developed by the panel of clinicians can be used in various healthcare settings to determine the next evidence- based step care; the goal of the pathway is to reduce unnecessary steps and eliminate variation among VFF patients' treatment. More satisfied patients can serve as a pillar of the hospital's reputation for outstanding patient care. The improved mobility and quality of life reported after vertebral augmentation also can impact society. Studies show that patients who previously had debilitating back pain were able to return to their daily activities and reduce opioid use. 10 This enables patients to avoid the ongoing costs of therapy, opioid prescriptions and specialist visits. A separate study also has shown that patients who received surgical intervention were less likely to suffer additional fractures than patients who underwent non-surgical treatment for their initial fractures. 11 Vertebroplasty or kyphoplasty is an important treatment option to consider in light of the burden of conservative treatment. Medicare and commercial payers cover vertebral augmentation, however providers should review the payer coverage policies to determine coverage criteria and clinical documentation requirements. "In today's challenging healthcare environment, every practice needs to be scrutinized — for care that is both quality and value- driven," Mr. Cambra said. "Medtronic advocates for continuous education for both patients and clinicians. For cases that are in question the pathway allows physicians to determine if vertebral augmentation would be an appropriate treatment choice." About Balloon Kyphoplasty (BKP) BKP is a minimally invasive procedure for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesion. The complication rate with BKP has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal. Risks of acrylic bone cements include cement leakage, which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as: cardiac arrest, cerebrovascular accident, myocardial infarction, pulmonary embolism, or cardiac embolism. For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices' Instructions for Use included with the product. VCF Clinical Care Pathway project was supported by a grant from Medtronic. However, Medtronic was not involved in the design or execution of the project, nor the preparation and review of this manuscript. Names of panel members were not disclosed to the sponsor, and panel members were not informed about the identity of the sponsor before submission of the manuscript. Conclusion As hospitals set strategies to improve patient care and healthcare related metrics, leaders should not overlook the significant number of Americans with back pain and VFF. Educated clinicians armed with the right tools and a strong referral network can identify and direct patients suspected with VFF to the appropriate specialist from the initial point of care, potentially eliminating unnecessary treatment down the road. Adherence to evidence-based care pathways is a big opportunity to care for vertebral compression fracture patients. It's time to give physicians a roadmap to success. For more information on VCF Carepathway visit: medtronic. com/vcfcarepath For more information on VC Mortality Risk visit: medtronic. com/bkpmortality References 1 Burg R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005- 2025. J Bone Miner Res 2007; 22:465-75. 2 Burg et al., Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res 2007; 22:465-75. 3 Burg et al., Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res 2007; 22:465-75. 4 Hirsch JA, Beall DP, Chambers MR, et al. Management of vertebral fragility fractures: a clinical care pathway developed by a multispecialty panel using the RAND/UCLA Appropriateness Method. Spine J. 2018. doi: 10.1016/j.spinee.2018.07.025. 5 Solomon DH, Finkelstein JS, Katz JN, Mogun H, Avorn J. Underuse of osteoporosis medications in elderly patients with fractures. Am J Med 2003; 115:398-400. 6 Hirsch et al. Management of vertebral fragility fractures: a clinical care pathway developed by a multispecialty panel using the RAND/UCLA Appropriateness Method. Spine J. 2018. doi: 10.1016/j.spinee.2018.07.025. 7 Hirsch et al. Management of vertebral fragility fractures: a clinical care pathway developed by a multispecialty panel using the RAND/UCLA Appropriateness Method. Spine J. 2018. doi: 10.1016/j.spinee.2018.07.025. 8 Hirsch et al. Management of vertebral fragility fractures: a clinical care pathway developed by a multispecialty panel using the RAND/UCLA Appropriateness Method. Spine J. 2018. doi: 10.1016/j.spinee.2018.07.025. 9 Boonen S, Van Meirhaeghe J, Bastian L, Cummings SR, Ranstam J, Tillman JB, Eastell R, Talmadge K, Wardlaw D. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results froma randomized trial. J Bone Miner Res. 2011 Feb 17. doi: 10.1002/jbmr.364 10 Pron G, Holubowich C, Kaulback K. "Vertebral Augmentation Involving Vertebroplasty or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: A Systematic Review. Ont Health Technol Assess Serv. 2016 May: 1;16(11): 1-202. 11 Papanastassiou ID, Phillips FM, Van Meirhaeghe J, Berenson JR, Andersson GB, Chung G, et al. Comparing effects of kyphoplasty, vertebroplasty and non-surgical management in a systematic review of randomized and non-randomized controlled studies. Eur Spine J 2012;21:1826-43. PMD022531-1.0 / UC201912668 EN