MEMPHIS, Tenn., Jun 30, 2011 (BUSINESS WIRE) --
Medtronic, Inc. (NYSE:MDT) today announced the commercial release of the Kyphon Xpander II Inflatable Bone Tamp (IBT) and the Kyphon Inflation Syringe - the Kyphon Xpander II IBT System - for the treatment of vertebral compression fractures with minimally invasive Kyphon(R) Balloon Kyphoplasty.
The new balloon material used in Kyphon Xpander II IBT System offers control during inflation and greater lifting force than the Kyphon Xpander IBT.* It is combined with the Kyphon Inflation Syringe, which provides ease of use to customers for use during a balloon kyphoplasty procedure. The Kyphon Xpander II IBT has been in physician preference testing since November 2010 in more than 180 cases throughout the United States.
Vertebral compression fractures are the most common osteoporotic fractures with an estimated 900,000i spinal fractures occurring in the U.S. every year. These fractures have shown to increase the likelihood of additional health problems as well as increase the risk of death.ii, iii
"Xpander II is a significant advancement to our existing kyphoplasty portfolio this year", said Doug King, Senior Vice President and President of Medtronic Spinal. "Combined with the recent launches of the quick-to-dough Kyphon Xpede(TM) Bone Cement and Kyphon Express(TM) Curette, we are delivering our most innovative, best-in-class technology to treat patients suffering from vertebral compression fractures."
About Kyphon Balloon Kyphoplasty:
During the minimally invasive balloon kyphoplasty procedure, a needle and tube are used to create a small pathway into the fractured bone, generally on both sides of the vertebral body. Orthopedic balloons are inserted and then inflated inside the fractured bone in an attempt to return it to its correct position. Inflation of the balloons creates cavities in the vertebral body that are filled with bone cement, forming an "internal cast" to support the surrounding bone and stabilize the fracture.
Balloon kyphoplasty differs from other surgical therapies for VCFs such as vertebroplasty, which is designed to stabilize the fracture without correcting vertebral body deformity or providing a controlled fill for bone cement distribution. With balloon kyphoplasty, inflation of the balloons compacts the cancellous bone, which may fill fracture lines. The presence of the space also allows a more viscous bone cement to be injected under low manual pressure.
The complication rate with Kyphon Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement leakage), including serious complications, and though rare, some of which may be fatal. This procedure is not for everyone. A prescription is required. Patients should consult their physicians for a complete list of indications, contraindications, benefits, and risks. Only patients and their physicians can determine whether this procedure is right for a particular patient.
About the Spinal Business at Medtronic
The Spinal 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 business works with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological, biologic, orthopedic, dental and spinal conditions along with biologics therapies for regeneration across a variety of musculoskeletal and other applications. 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.
About Medtronic
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.
Kyphon Balloon Kyphoplasty incorporates technology developed by Gary K. Michelson, M.D.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
* While this data is supported with Medtronic performance bench testing, it has not been correlated to human clinical performance of the device.
i Medtronic, Inc. updated estimate from 700,000 spinal fractures estimated in 1985-89 study published by Riggs & Melton - Bone. 1995;17(5 Suppl):505S-511S] for demographics and incidence rate per Burge R, et al. J Bone Min Res. 2007;22:465-475.
iiSilverman SL, et al. The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation Study. Arthritis Rheum. 2001 Nov;44(11):2611-9.
iii Lau E, et al. Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2008 Jul;90(7):1479-86.
SOURCE: Medtronic, Inc.
Medtronic, Inc. Public Relations: Victor Rocha, 901-399-2401 or Investor Relations: Jeff Warren, 763-505-2696