Press Release

AIRvance™ Bone Screw System Gains Additional FDA Clearance

The AIRvance™ 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™ 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™ Bone Screw System
The AIRvance™ 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™ 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 –


Medtronic Media Contacts:
Natalie St. Denis, Public Relations, +1-720-890-3314
Jeff Warren, Investor Relations, 763-505-2696
X