MINNEAPOLIS–(BUSINESS WIRE)–Medtronic Inc. (NYSE:MDT) today announced the launch of the new KYPHON® Express™ Curette for scraping or scoring bone in the spine, including during treatment of vertebral compression fractures with minimally invasive KYPHON® Balloon Kyphoplasty.
“As the leader and inventor of KYPHON Balloon Kyphoplasty, Medtronic is committed to the continued advancement of this important and specialized treatment to ensure the best outcomes for patients who suffer from debilitating spinal fractures”
The Kyphon Products Division of Medtronic Spinal and Biologics will showcase the new curette, along with the recently launched KYPHON® Cement Delivery System (CDS) and KYPHON® ActivOs™ 10 Bone Cement with Hydroxyapatite (HA), at the North American Spine Society (NASS) meeting in Orlando, FL taking place October 5-9, 2010 and at the Congress of Neurological Surgeons (CNS) annual meeting October 16-21, 2010 in San Francisco.
The KYPHON Express Curette is designed to maximize control when scraping or scoring bone in the spine. This product is available in T-tip with a torque resetting device, which allows easy resetting of the device when the tip encounters excess torsion. It is compatible with Kyphon® Express™ access tools in the Size 2 offering. KYPHON Express Curette is currently available.
This new product is a continuation of the industry-leading advancements Medtronic has made over the past 10 years in the treatment of vertebral compression fractures – the most common osteoporotic fractures with an estimated 900,000i spinal fractures occurring in the U.S. every year. Left unrepaired, spinal fractures can cause additional health problems that increase the risk of mortality.ii iii
“As the leader and inventor of KYPHON Balloon Kyphoplasty, Medtronic is committed to the continued advancement of this important and specialized treatment to ensure the best outcomes for patients who suffer from debilitating spinal fractures,” said Alex DiNello, vice president and general manager of the Kyphon Products Division. “Since we introduced balloon kyphoplasty in 2000, an estimated 800,000 fractures have been treated worldwide with KYPHON Balloon Kyphoplasty by approximately 14,500 trained spine specialists.”
Other recent products being shown at NASS and CNS by the Kyphon Products Division are:
- KYPHON ActivOs 10 Bone Cement with HA – Formulated with 10 percent HA by weight in the powder, this cement has been showniv in an animal trial to provide direct bony apposition on the surface of the cement without any intervening fibrous tissue layer.v vi HA is a specific crystalline compound containing calcium and phosphate, which is similar to the mineral portion of bone.vii KYPHON ActivOs 10 was launched on June 21, 2010.
- CDS – Allows for the controlled delivery of KYPHON HVR® Bone Cement at a safer distance with a one‐handed operation, preserving some tactile feel during delivery with the ability to halt bone cement flow on demand with the quick‐release button. CDS was launched on September 21, 2009.
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 and reduce leak pathways. 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.
For more information on these new product offerings, go to www.kyphon.com.
About the Spinal and Biologics Business at Medtronic
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 andwww.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.
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.
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.
ii Silverman 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.
iv KYPHON ActivOs 10 Bone Cement was implanted into rabbit femurs (n=8) and 2 rabbits were harvested at each 1, 6, 9 and 12 month time point. Stained histological sections showed new bone formation on the cement surface.
v This phenomenon has not been assessed in clinical trial and may not be predictive of clinical experience.
vi The addition of HA has not been shown to provide any improved clinical benefits.
vii LeGeros RZ. Properties of Osteoconductive Biomaterials: Calcium Phosphates. Clinical Orthopaedics and Related Research. 2002 Feb; 395:81-98