Kiva® VCF Treatment System Newsletter Article Template – Osteoporosis Awareness Month Focus Finally Free from Back Pain Treatment Helps Those with Spinal Fractures Caused by Osteoporosis Get Back to What They Love In honor of National Osteoporosis Prevention and Awareness Month in May, [Hospital] is providing information about a lesser-known but prevalent osteoporosis-related fracture risk, as well as the innovative treatment offered at our hospital. If you or a loved one has been diagnosed with osteoporosis, you may be worried about hip and wrist fractures caused by falls. But there’s another fracture that occurs nearly twice as often: spinal fractures known as vertebral compression fractures (VCFs) happen when a vertebra (bone in the spine) cracks, fractures or collapses. In the U.S., 750,000 patients each year suffer a VCF. They are most often caused by osteoporosis: When bones become fragile and brittle from osteoporosis, everyday activities can trigger VCFs. 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. They are a serious condition and frequently go undiagnosed. [Introduction to patient story (if available), such as: When XX-year-old [name] missed a step and landed on the ground, [he/she] was happy to not have broken [his/her] hip. But lingering back pain after the fall became so severe that [he/she] could no longer stand, much less walk. A trip to [his/her] family physician resulted in a surprising diagnosis: an osteoporosis-related VCF.] 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 – especially those who have been diagnosed with or are at risk for osteoporosis – 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 and negatively impact the overall health of the individual, their 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 often provides immediate pain relief and functional improvement. [Hospital] is the first hospital in [City or State] to treat VCFs using a new approach to vertebral augmentation called the Kiva VCF Treatment System. The Kiva System uses a cylindrical implant that is delivered through a single incision no wider than a traditional ballpoint pen. The implant is designed to support the vertebra, 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 the current standard vertebral augmentation procedure – called balloon kyphoplasty – 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 ML10016.A Kiva® VCF Treatment System Newsletter Article Template – Osteoporosis Awareness Month Focus 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 and talk to your doctor. Sample physician quote: “The Kiva System is a proven, minimally invasive alternative that offers important advantages for my patients over current procedures. 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,” Dr. [last name] said. “Similar to hip fractures, we are beginning to recognize that it is important to treat patients incapacitated with painful VCFs without delay to prevent a downward spiral in their health and well-being.” [Patient’s procedure experience, such as: [Patient] received the Kiva implant in a procedure that lasted about an hour. Just days after the surgery, [he/she] reported being relieved 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 ### ML10016.A