New Multicenter Balloon Kyphoplasty Study Shows Long-Term Benefits for
Osteoporosis Patients

Two-Year Data Demonstrate Significant and Sustained Improvements in Back Function, Back Pain and
Quality of Life

SUNNYVALE, Calif., September 5, 2006 (PR NEWSWIRE) - Kyphon Inc. (Nasdaq:KYPH) announced today that results from the first multicenter long-term, prospective clinical study evaluating the benefits of balloon kyphoplasty treatment of osteoporotic spinal fractures were published in the September 1, 2006 issue of Spine.  This latest study in the growing body of evidence for balloon kyphoplasty showed that patients experienced rapid and sustained improvement in back pain, back function and quality of life for two years post-procedure.  In addition, the study documented improvements in restoring vertebral height and high patient satisfaction with the procedure.

"The safety and immediate benefits of balloon kyphoplasty demonstrated in this multicenter, prospective, practice-based study are consistent with those reported in smaller studies, indicating that balloon kyphoplasty should be considered for pain relief, functional improvement and restoration of anatomic alignment for patients diagnosed with a painful osteoporotic spinal fracture," reported lead study author, Steven R. Garfin, M.D., from the University of California, San Diego.

"We are very pleased with the results from this important two-year multicenter study, which provides further clinical proof of the positive long-term impact of balloon kyphoplasty in treating spinal fractures caused by osteoporosis," said Richard Mott, president and chief executive officer of Kyphon.  "This publication represents a significant milestone in demonstrating the maintenance of benefits realizable through the application of balloon kyphoplasty for a broad range of patients across multiple centers," Mott concluded.

Study Details

The study, sponsored by Kyphon Inc., was conducted at 19 U.S. centers and evaluated 155 elderly patients with 214 spinal fractures caused by primary osteoporosis, secondary osteoporosis, or multiple myeloma. Multiple outcomes relating to back pain, quality of life, patient satisfaction and degree of difficulty performing certain daily activities were evaluated out to two years following balloon kyphoplasty.  Follow-up information was obtained on 150 patients at seven days (VAS pain only), 140 at one month, 134 at three months, 119 at 12 months, and 100 at 24 months. None of the fifty-five patients who did not complete the 24 months of follow-up withdrew because of a procedure-related adverse event.

Before undergoing balloon kyphoplasty, the study patients experienced debilitating back pain and limited function associated with spinal fractures.  Activities of daily living such as bending over or lifting a 10-pound object could not be performed without difficulty in the majority of patients.  Quality of life as measured by SF-36 was greatly diminished. Following the procedure, patients had significant, immediate and sustained improvement in measurements of pain, function, and quality of life.

The study results demonstrated the following:

• Improved back function - The ability to perform common activities such as lifting or bending to pick up a lightweight object and standing for one hour without difficulty improved from approximately 20% of patients before balloon kyphoplasty to over 50% within one month and sustained or increased through 24 months.  The average number of days per month that back pain limited or qualitatively impacted the patients' daily activities was at minimum cut in half and in some cases decreased by as much as 80% over the 24 month follow-up period when compared to the month before the procedure.
• Significant reduction in back pain - Patients experienced significant reduction in back pain and decreased number of days of bed rest.  VAS pain scores decreased 60% (from 15 to 6 as rated on a scale of 1 -20) within seven days after kyphoplasty and were maintained throughout the two years of follow-up.  At 24-month follow up, 87% of patients reported no days in bed due to back pain during the preceding 28-day period, compared to only 46% before having kyphoplasty.
• Improved quality of life - All SF-36 quality of life measures improved immediately and significantly after balloon kyphoplasty (except for General Health), including Role Physical, Bodily Pain and Social Function.  These improvements were maintained throughout the 24-month follow-up period.

Study patients were also extremely satisfied with the procedure, giving balloon kyphoplasty a mean rating of 18 out of 20 at seven days after the procedure.  Complete satisfaction (rating of 20) was consistently reported by over half of patients throughout the study period. Importantly, there were no major adverse device- or procedure-related complications reported in the study; however, as with most surgical procedures, there are risks associated with balloon kyphoplasty, including serious complications, although the complication rate with balloon kyphoplasty has been demonstrated to be low.

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 275,000 spinal fractures have been treated using the balloon kyphoplasty procedure worldwide.

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 is 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.

Kyphon and KyphX are registered trademarks of Kyphon Inc.

For additional downloadable media materials, click here.
To request a full copy of the study, click here.
To find a Spine Specialist who performs Balloon Kyphoplasty in your area, click here.

Learn More About Spinal Fractures

Related References

Related Links

Investors and Media Contact Information

Dr. Garfin Video

Windows Media 56/150k 300k Real Player 56/150k 300k

B-Roll Video

Windows Media 56/150k 300k Real Player 56/150k 300k

Animation Video

Windows Media 56/150k 300k Real Player 56/150k 300k