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

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:
 Sudden onset of severe, “knifelike" back pain
 Chronic or gradual onset of back pain that worsens when standing or
walking
 Additional symptoms of multiple VCFs:
 Eventual loss of height, as much as six inches over
time
 Kyphosis (curved back), commonly called a
dowager’s hump
 Stomach complaints
 Hip pain
 Breathing problems
Courtesy of Nucleus Medical Art, Inc.
Treatment of Symptomatic VCFs
Treatment options:

Bed rest for severe pain

Prolonged pain and rest leads to loss of function and possible loss of
independence

Analgesics and opoids

Physical therapy

Bracing

Steroid injections

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
 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

BKP patients had improved outcomes in terms of pain reduction,
quality of life, function and mobility compared to non-surgical
care

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:
 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:
New fracture risk
Cement leakage
Improve:
 Kyphotic angle correction
 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

Stabilize the bone while using less cement

Predictable implant structure
 Approximates natural bone
characteristics


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
 Improve kyphotic angle restoration
 Reduce rate of cement leakage into surrounding tissue


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
• 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
Comparison of Balloon
Kyphoplasty with the
New Kiva VCF System
for the Treatment of
Vertebral Compression
Fractures
Pain Physician
Journal
Sept./Oct. 2013
52
patients
• 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

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:

Have similar mortality to hip fractures and so we need to be
vigilant in diagnosis and treatment

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.
Questions?