SUNNYVALE, Calif., Jan. 11 /PRNewswire-FirstCall/ -- Kyphon Inc. , announced today that outcomes data for patients followed for two years post-treatment with balloon kyphoplasty were published for the first time in the January 1, 2006 issue of Spine, the leading subspecialty, peer- reviewed journal reporting on spinal disorders.
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The retrospective single-center case series was analyzed by Jon Ledlie, MD, and Mark Renfro, MD, neurosurgeons from the Tyler Neurosurgical Associates in Tyler, Texas. The case series studied clinical and radiological (X-ray) outcomes in consecutive patients before and after balloon kyphoplasty, a minimally invasive procedure for the treatment of spinal fractures caused by osteoporosis or cancer. Based on the data collected, the authors concluded that kyphoplasty markedly improved pain and function, and resulted in significant vertebral height restoration and normalization of vertebral body shape indexes that were maintained for at least two years following treatment.
“Our study shows that using balloon kyphoplasty to repair spinal fractures provides immediate and sustained improvements in function and mobility, a significant benefit for elderly patients,” commented Dr. Ledlie. “Prior to treatment, the vast majority of patients could not walk without assistance and required the strongest prescription medications to control pain. One week after the procedure, more than three quarters of the patients could walk independently and without difficulty, and more than half no longer needed pain medication of any type. Two years after treatment, patients reported continued, and in some cases, improved, pain relief as well as ability to ambulate independently. Though not reported in the study, some patients have reached five years of follow-up, reporting continued pain relief,” continued Dr. Ledlie.
This study contributes to the growing body of evidence published in the peer-reviewed clinical literature that consistently shows balloon kyphoplasty to be effective for treating spinal fractures caused by osteoporosis or cancer. “While earlier reports included short- and mid-term follow-up, the study published by Drs. Ledlie and Renfro is the first publication of two-year maintenance of balloon kyphoplasty benefits, further establishing the durable effects of the procedure,” said Richard Mott, president and chief executive officer of Kyphon. “The publication of two-year follow-up data represents a significant milestone in documenting the benefits of the balloon kyphoplasty procedure,” Mott concluded.
Study Details
In the study, 117 consecutive patients (151 spinal fractures) treated with balloon kyphoplasty were assessed for change in spinal deformity, pain scores, analgesic usage and ambulatory status. Data were collected preoperatively, at 1 week and at 3, 6, 12, and 24 months following the procedure, with a subset of 77 patients (97 spinal fractures) completing at least two years of follow- up. Forty patients were lost to follow-up, either due to inability to contact or to death for reasons unrelated to the study (average patient age = 77 years). Analysis of demographic and clinical parameters showed no differences between subjects who completed two years of follow-up versus those who did not; therefore, the authors believe that the two-year results are valid and can be extended to the entire study population. The majority of patients suffered spinal fractures due to osteoporosis and did not respond to conventional therapy, comprising one or more of pain therapy, bed rest and bracing, prior to undergoing balloon kyphoplasty.
Correction of Vertebral Deformity
Nearly half of all fractures included in the case series had at least a 50 percent collapse prior to treatment. Vertebral heights significantly increased and were sustained throughout follow-up, with 90 percent of fractures treated demonstrating at least a 10 percent height increase compared to adjacent control vertebrae. The rate of new symptomatic fractures per patient was less than five percent per year. Two concurrently controlled studies, which were also recently reported, showed a statistically significantly reduced rate of new fracture following balloon kyphoplasty when compared to non-surgical management.
Significant and Maintained Improvement in Pain and Ambulation
Among the 77 patients followed for two years, two percent could walk independently prior to treatment, and 81 percent required narcotic analgesics for pain. One week after balloon kyphoplasty, 76 percent of the patients could walk without difficulty, 19 percent required narcotic analgesics, and more than 50 percent required no type of pain medication. Two years later, 81 percent of the treated patients could walk independently, 10 percent required narcotic pain medications, and 80 percent did not need any pain medications. Sixty-eight percent of patients reported complete pain relief at one week, 86 percent reported complete pain relief by six months, and 90 percent of patients reported complete pain relief at two years. There were no balloon kyphoplasty-related complications in the 117 patients treated.
Spinal Fractures and Balloon Kyphoplasty
The majority of spinal fractures are caused by osteoporosis, a progressive disease that causes bones to become brittle, weak and susceptible to painful, debilitating fractures. According to the National Osteoporosis Foundation, one in two women and one in four men over the age of 50 in the U.S. will experience a spinal fracture, with two-thirds going undiagnosed. Cancer, including multiple myeloma and the metastasis of other tumors to bone, can also affect bone quality and lead to spinal fracture. In cases of multiple spinal fractures, a loss of height and stooped posture -- known as kyphosis -- can occur, which affects the ability to stand upright and walk, and can make simple tasks like lifting a bag of groceries or getting dressed difficult. Left untreated, each additional fracture increases future fracture risk, accelerating the effects of the spinal deformity. Increasing kyphosis is associated with decreased respiratory function, reduced ability to walk, decreased quality of life, and an increased risk of early mortality.
Supplemental calcium with vitamin D and prescription medications are often used to slow down bone loss and treat the underlying osteoporosis. Medical management, however, does not always prevent fracture. Despite the advances in drug therapy, spinal fractures continue to occur and may require surgical intervention. First performed in 1998, balloon kyphoplasty is a minimally invasive procedure which can treat the fracture, reduce pain, restore quality of life, and repair some or all of the associated deformity. To date, over 200,000 spinal fractures have been treated using the balloon kyphoplasty procedure worldwide.
Although the complication rate with balloon kyphoplasty has been demonstrated to be low, as with most surgical procedures, there are risks associated with balloon kyphoplasty, including serious complications. Patients should consult with their doctor for a full discussion of risks.
About Kyphon Inc.
Kyphon develops and markets medical devices designed to restore spinal function using minimally invasive technologies. The company’s KyphX line of products are used in balloon kyphoplasty, a minimally invasive procedure to treat spinal fractures caused by osteoporosis or cancer. For more information, visit Kyphon’s Web site at www.kyphon.com.
NOTE: Kyphon and KyphX are registered trademarks of Kyphon Inc.
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CONTACT: Julie D. Tracy, Vice President, Investor Relations and CorporateMarketing, +1-408-548-6500, or jtracy@kyphon.com
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