Painful VCFs How and When to Treat Them

Painful VCFs: How and When to Treat Them?

Agenda �Background on VCFs �Diagnosis �New Information on Treatment Options �A New, Implant-based Approach �Case Studies �Summary and Conclusions

Background � 750, 000 Vertebral Compression Fractures (VCFs) in US each year caused by osteoporosis � Osteoporosis causes twice as many spinal fractures than hip fractures � Yet VCFs often go undiagnosed and untreated � Estimated that two-thirds of VCFs are never diagnosed Ø Many patients dismiss their back pain as a sign of aging and/or arthritis

Similar Mortality in Hip Fracture and VCF Patients Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

Biomechanics of Kyphosis: “Kyphosis begets Kyphosis” Balanced Force Concentration Force Transmission

VCFs Increase Risk of Subsequent Fragility Fracture Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

Consequences of Kyphosis • Deformity • Debilitation • Disability • Depression • Death Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

Diagnosis � Patients may experience either: Ø Sudden onset of severe, “knifelike" back pain Ø Chronic or gradual onset of back pain that worsens when standing or walking � Additional symptoms of multiple VCFs: Ø Eventual loss of height, as much as six inches over time Ø Kyphosis (curved back), commonly called a dowager’s hump Ø Stomach complaints Ø Hip pain Ø Breathing problems Courtesy of Nucleus Medical Art, Inc.

Treatment of Symptomatic VCFs Treatment options: Ø Bed rest for severe pain � Prolonged pain and rest leads to loss of function and possible loss of independence Ø Analgesics and opoids Ø Physical therapy Ø Bracing Ø Steroid injections Ø Minimally Invasive Vertebral Augmentation § § Vertebroplasty Balloon kyphoplasty Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

FREE Study Shows Benefits of BKP Treatment �FREE: Fracture REduction Evaluation Study Ø 300 patient, multicenter, randomized, controlled study designed to compare BKP to non-surgical care for acute VCF patients �Trial results were published in The Lancet and demonstrated Ø BKP patients had improved outcomes in terms of pain reduction, quality of life, function and mobility compared to non-surgical care Ø BKP had increased rates of new fractures (33%) compared to non -surgical care (25%) at one year Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE) Study, Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Lancet. 2009 Mar 21; 373(9668): 1016 -24. Epub 2009 Feb 24.

FREE Study Shows Benefits of Earlier BKP Treatment • On average, the BKP patients in FREE were treated at 5. 6 weeks • By one month post-treatment, compared to nonsurgical patients, BKP patients experienced: Ø Greater improvement on most measures • Findings suggest that BKP may be considered earlier to provide faster pain relief and improved function.

Vertebral Augmentation: Room for Improvement � Unmet needs: Decrease: ØNew fracture risk ØCement leakage Improve: Ø Kyphotic angle correction Ø Deployment predictability � 10 years of very little innovation in vertebral augmentation � Until Now: a new implant-based approach

About the Implant-based Approach �Structurally-supportive Implant Ø Stabilize the bone while using less cement Ø Predictable implant structure �Approximates natural bone characteristics Ø Ø Made of medical polymer Provides flexible, structural support �Implanted over removable guidewire, then filled with bone cement

Kiva in Action �Insert Kiva Animation

Impressive Clinical Evidence Supports Implant �In three separate comparative studies, Kiva has been demonstrated to meet or exceed the performance of BKP 1 2 3. �In one or more of these studies, as compared to BKP, Kiva was shown to: Reduce rate of adjacent level fractures Ø Improve kyphotic angle restoration Ø Reduce rate of cement leakage into surrounding tissue Ø Ø Reduce cement volume 1 KAST IDE Study: The Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial 2 Otten, Pflugmacher, et al. Pain Physician Journal, October 2013 3 Korovessis et al. Spine, February 2013

Study KAST (Kiva System as a Vertebral Augmentation Treatment – A Safety and Effectiveness Trial) Publication Presented at Society for Interventional Radiology 2014 Scientific Meeting, March 26, 2014 Size Results 300 patients Improvement in pain and function were similar to balloon kyphoplasty • Reduced rate of adjacent level fractures as compared to balloon kyphoplasty - per protocol population* • Reduced rate of extravasation as compared to balloon kyphoplasty - as reported by Investigators* • Significant reduction in cement volume over balloon kyphoplasty* *Posterior probability of superiority was > 90% Balloon Kyphoplasty versus Kiva Vertebral Augmentation. Comparison of Two Techniques for Osteoporotic Vertebral Body Fractures Spine Feb. 15, 2013 168 patients Comparison of Balloon Kyphoplasty with the New Kiva VCF System for the Treatment of Vertebral Compression Fractures Pain Physician 52 Journal Sept. /Oct. patients 2013 • Significant restoration of the Gardner angle in patients treated with Kiva, whereas ballon kyphoplasty did not meet significance • Lower extravasation rates with Kiva • Lower cement volume with Kiva VAS, ODI, and SF-36 were similar • Significantly lower rate of new fractures following treatment with Kiva • Pain improvement was significantly better with Kiva at 6 months • Mean cement used was less than half with Kiva

Additional Implications of KAST �Patients in both the Kiva and kyphoplasty group showed substantial improvements over baseline Ø Although Kiva showed distinct advantages ● Patients treated as early as 2 weeks post onset of pain demonstrated marked improvement by 7 days post intervention.

Kiva Case from KAST

Sample Kiva Case Courtesy of Wayne Olan, MD, Director of Interventional & Endovascular Neurosurgery George Washington University Medical Center

Summary: Vertebral Fractures… �Are the most common osteoporotic fractures �Increase the risk of subsequent VCFs by 5 -fold and the risk of other fragility fractures (including hip) by 2 - to 4 -fold �Multiple VCFs: Ø Have similar mortality to hip fractures and so we need to be vigilant in diagnosis and treatment Ø Are associated with significant morbidity, even if they do not come to clinical attention Source: International Osteoporosis Foundation: Vertebral Fracture Initiative

Three Takeaways 1. FREE study showed benefits of vertebral augmentation over non-surgical care. 2. New clinically proven, implant-based approach to vertebral augmentation meets or exceeds the performance of BKP. 3. There is clinical evidence showing the benefits of treating acute VCF patients earlier than 6 weeks with vertebral augmentation.

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