Medtronic Announces 510(K) Clearance for the TSRH® Spinal System Pedicle Screw for the Treatment of Adolescent Idiopathic Scoliosis
AIS is the Most Common Type of Scoliosis Seen in Adolescents and Affects Nearly One Million Adolescents in the U.S. Alone
MDT, Medtronic, Inc.
Medtronic (NYSE: MDT) announced it received a second clearance from the Food and Drug Administration (FDA) to treat adolescent idiopathic scoliosis (AIS) with pedicle screws. The TSRH® Spinal System is the second posterior fixation system by Medtronic to receive 510(k) clearance for this indication and Medtronic remains the only company with this clearance under the Agency’s product category for pediatric AIS patients treated with posterior pedicle screw instrumentation.
Adolescent idiopathic scoliosis (AIS) is the most common pediatric spine condition, and its cause is unknown. Many patients with AIS have rotated and/or curved spines, which may resemble an "S" or "C" shape instead of a straight line seen with normal spines. Some of the bones in the spines of AIS patients can rotate, causing the shoulders or waist to appear uneven. If the curvature of the spine progresses as the patient grows, it could compress nerve roots and the spinal cord.
“This additional AIS clearance will further afford Medtronic the ability to provide training and education to spine surgeons treating patients diagnosed with AIS,” said Doug King, vice-president and president of Medtronic Spinal. “This clearance also provides an opportunity to further research and study these patients allowing us to move forward with our commitment and investment in pediatric innovation.”
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.
AuthenTec, Inc. (Nasdaq:AUTH), a leading provider of security and identity management solutions, announced that NEC Corporation (NEC) has chosen its QuickSec VPN Client solution for enterprise-class security in its new LifeTouch® NOTE models for business and LifeTouch Security Pack Android tablet models to be launched in Japan. AuthenTec's Android VPN solution supports critical VPN features for LifeTouch users and is compatible with a wide variety of networking devices, including all major VPN gateways.
AuthenTec, Inc. provides security, identity management, and touch control technologies for PC, wireless device, and information technology markets primarily in the Asia Pacific, Japan, the United States, Canada, and Europe.
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September 16th, 2011 at 03:38 pm