One-Year Data Shows Better Quality of Life, Back Function and Pain Reduction with Minimally Invasive Surgical Procedure
MINNEAPOLIS – Feb. 24, 2009 – In the largest multicenter randomized controlled study of surgical intervention versus non-surgical care for acute vertebral compression fractures, patients undergoing balloon kyphoplasty showed superior improvement in quality of life, back function and back pain compared to those who had non-surgical care alone one month after surgery. The benefits of balloon kyphoplasty were sustained on average throughout 12 months.
The study of 300 patients at 21 centers in eight countries was published in the Feb. 24 online edition of The Lancet and provides clinical evidence of improved outcomes with balloon kyphoplasty when treating patients with acute fractures.
The study was sponsored by the Spine and Biologics business at Medtronic, Inc. (NYSE: MDT) and supports the benefits of surgical intervention specifically with balloon kyphoplasty compared to non-surgical care. Devices to perform balloon kyphoplasty are sold as KYPHON® products by Medtronic.
Study results of additional outcome measures show that balloon kyphoplasty patients experienced faster and significantly greater improvements in quality of life, back pain and back function for at least one year when compared to patients receiving non-surgical treatments. Balloon kyphoplasty patients also reported fewer days of limited activity and less use of analgesics or walking aids than those solely receiving non-surgical management. The frequency of adverse events did not differ between the groups. Balloon kyphoplasty did not result in a significant increase in new vertebral fractures as shown on X-rays at one year compared to patients receiving non-surgical care.
“This landmark study shows that balloon kyphoplasty is an effective treatment option for patients with acute, symptomatic vertebral fractures. This minimally invasive procedure, which has been performed on more than 500,000 patients worldwide, has been demonstrated in this study to be superior to non-surgical management in restoring patients’ physical function, reducing their pain and improving their quality of life,” said Professor Douglas Wardlaw, lead author of the study and consultant spine surgeon NHS Grampian, Aberdeen, Scotland.
For more detailed information on the findings of the study, click here.
About Balloon Kyphoplasty
Balloon kyphoplasty is a minimally invasive treatment for vertebral compression fractures. It is used worldwide to treat vertebral compression fractures caused by osteoporosis and certain types of cancer and has also been approved outside the United States for the treatment of vertebral compression fractures caused by trauma. Balloon kyphoplasty is unique to other surgical treatments for vertebral compression fractures with its use of a balloon to restore vertebral body height and angular deformity in addition to stabilizing the fracture. Kyphon, which is part of the Spinal and Biologics business at Medtronic, is the pioneer of this innovative and unique proprietary technology.
About Osteoporosis and Vertebral Compression Fractures
Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures of the hip, spine and wrist. Osteoporosis is the main cause of the estimated 1.4 million vertebral compression fractures suffered annually worldwide that come to clinical attention.1 Osteoporosis increases the risk of subsequent spinal fractures after an initial spinal fracture, causes spinal deformity, generates debilitating pain, and leads to other serious health problems, as far as increasing patients’ mortality rate.
About Medtronic’s Spinal and Biologics Business
The Spinal and Biologics business is based in Memphis, Tenn. It is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. The Spinal and Biologics business works with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, orthopedic, dental and spinal conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle-friendly surgical therapies. More information about the company and its treatment therapies can be found at www.medtronic.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.
Balloon kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.
1Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006;17(12):1726-33.
Medtronic Media Contacts:
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Denise Moore, Public Relations, 408-548-5394