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AIRvance(TM) Bone Screw System Gains Additional FDA Clearance


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Copyright © Thomson Reuters 2013. All rights reserved.
2013-02-13 20:01:03 -

The AIRvance((TM)) Bone Screw System Is Now Suitable for the Performance of a
    Hyoid Suspension Procedure, Which Can Be Used in Combination with Other
            Procedures for the Treatment of Obstructive Sleep Apnea

MINNEAPOLIS - Feb. 13, 2013 - Medtronic announced today that it has received
Food and Drug Administration (FDA) clearance for its AIRvance(TM) Bone Screw
System that allows surgeons to perform a hyoid suspension procedure
independently or in combination with other procedures for the treatment of
obstructive sleep apnea (OSA). Under the previous FDA clearance the hyoid
suspension procedure was indicated as an adjunct to the tongue suspension
procedure.  This latest FDA clearance makes the AIRvance System the only
combined system available for performing 
a hyoid suspension procedure as well a tongue suspension procedure. "This is good news for ENT surgeons and their patients with OSA," says M. Boyd Gillespie, M.D., Professor of Otolaryngology-Head and Neck Surgery at the Medical University of South Carolina, "We now have the option of treating patients with either or both procedures based on what's best for the patient." Gillespie adds, "There are many places in the airway that can be obstructed and contribute to OSA. Surgeons can now perform the hyoid suspension procedure as a stand-alone procedure to treat hypopharyngeal-based obstructions or in conjunction with other targeted procedures as a comprehensive surgical approach to treating OSA." In addition, the American Academy of Otolaryngology - Head and Neck Surgery recently endorsed tongue suspension as an effective treatment for managing patients with OSA. About The Medtronic AIRvance(TM) Bone Screw System The AIRvance(TM) Bone Screw System is designed to treat obstructive sleep apnea (OSA) and/ or snoring using a surgical approach to suspend the tongue to prevent it from collapsing into and obstructing the airway during sleep. It can also be used to perform a hyoid suspension procedure to address obstructing tissues lower in the airway. Since the AIRvance(TM) Bone Screw System was introduced in 1999 it has been used to treat more than 15,000 people worldwide with sleep disordered breathing problems including snoring and OSA. For more information, visit:  www.airvanceprocedure.com www.medtronicent.com About Medtronic Surgical Technologies The Surgical Technologies business develops products and procedural solutions for surgical applications that include: neuro spine, cranial and orthopedics; ear, nose and throat; and surgical oncology. Surgical Technologies designs, develops, manufactures and supports healthcare providers with advanced surgical navigation and imaging solutions, powered surgical tools and systems, intraoperative nerve monitoring devices, advanced energy-based devices for hemostatic sealing and tissue dissection, and implantable devices for hydrocephalus management. About Medtronic Medtronic, Inc. (NYSE: MDT) (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 periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. - end - Contacts: Natalie St. Denis Public Relations +1-720-890-3314 Jeff Warren Investor Relations +1-763-505-2696 This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Medtronic, Inc. via Thomson Reuters ONE [HUG#1677593]


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