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Kiva

®

VCF Treatment System

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Finally Free from Back Pain

Treatment Helps People with Spinal Fractures Get Back to What They Love

[Introduction to patient story, such as: When XX-year-old [name]’s back pain became so severe that

[he/she] could no longer stand, much less walk, [he/she] decided that it was something more than aging or arthritis. A trip to [his/her] family physician resulted in a surprising diagnosis: a vertebral compression fracture, or VCF.]

VCFs occur when a vertebra (bone in the spine) cracks, fractures or collapses. They are a serious condition and frequently go undiagnosed. VCFs are most often caused by osteoporosis: When bones become fragile and brittle from osteoporosis, everyday activities can trigger vertebral compression fractures. Bending to lift an object or picking something up off the floor, missing a curb or slipping on a wet surface can put the spinal bones at risk of fracture.

Sample physician quote: “It is estimated that two-thirds of VCFs are never diagnosed because many patients dismiss their back pain as a sign of aging and/or arthritis,” said [name, title of physician, hospital]. “Because vertebral compression fractures are under-diagnosed and undertreated, it is important that people with intense, debilitating pack pain speak with their physician about the possibility of a VCF and available treatments.”

Without intervention the pain may subside as the fracture heals, but the vertebra heals in its deformed, compressed position. This shortened, compressed vertebra alters the normal alignment of the spine, putting the spine at greater risk for additional fractures. When multiple vertebral compression fractures have occurred, there is a significant change in the structure and shape of the spine. This structural change can affect the internal organs and body functions, negatively impacting the overall health of the individual, daily activities, and quality of life.

The primary treatments for VCFs typically include bed rest, pain medicines, physical therapy and back braces, or a minimally invasive procedure called vertebral augmentation, which aims to stabilize the fracture with bone cement, and provide pain relief and functional improvement.

[Hospital] is the first hospital in [City or State] to treat VCFs using a vertebral augmentation treatment called the Kiva VCF Treatment System. The Kiva System uses a cylindrical implant that is delivered through a singleincision no wider than a traditional ballpoint pen. The implant is designed to provide a predictable structural support to the vertebral body, and direct and contain the bone cement that is used to repair VCFs. In clinical studies, the Kiva System was shown to meet or exceed the performance of balloon kyphoplasty – the current standard vertebral augmentation procedure - for the treatment of

VCFs. In one or more of these studies, patients who received Kiva experienced the same pain relief and functional improvement, but Kiva patients were less likely to have the bone cement leak, less likely to suffer another fracture in adjacent vertebra and more likely to have the natural alignment of their spine restored. As with other vertebral augmentation devices and procedures, there are risks and considerations for use of the Kiva VCF Treatment System. The risks include serious complications up to and including death. Please see the product labeling for a more detailed discussion of risks, contraindications, warnings and precautions.

Sample physician quote: “The Kiva System is a minimally invasive alternative that significantly reduces pain and restores function, and it offers important advantages for my patients over current procedures,”

Dr. [last name] said “Our use of the Kiva System at [hospital] further demonstrates our commitment to providing our patients with access to the most advanced treatments available today that are proven under the highest scientific standards.”

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Kiva

®

VCF Treatment System

Newsletter Article Template

[Patient’s procedure experience, such as: [Patient] received the Kiva implant in a procedure that lastedabout an hour. Just days after the surgery, [he/she] reported being relived of his/her pain.]

Sample patient quote: “I can’t believe I endured severe pain for so long,” [patient] said “The Kiva procedure was so easy. I went home the same day and have already returned to [activity].

For more information about the Kiva system, visit [hospital website] or call [hospital call center].

Sidebar: VCF Symptoms

The symptoms associated with a vertebral compression fracture vary considerably from individual to individual. Following are the most common symptoms associated with osteoporosis-related fractures:

Sudden onset of severe, “knifelike" back pain

Chronic or gradual onset of back pain

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

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