Medtronic, Inc. : AIRvance(TM) Bone Screw System Gains Additional FDA
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:
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
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
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Natalie St. Denis
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Source: Medtronic, Inc. via Thomson Reuters ONE
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