Marking a major milestone in the advancement
of new treatments for peripheral artery disease, Medtronic, Inc. MDT
today announced the submission of its first pre-market approval (PMA) module
to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral
drug-eluting balloon. Designed to treat atherosclerotic lesions in the
superficial femoral artery (SFA), the novel angioplasty device remains
investigational in the United States.
"Pending FDA approval, we remain on track to launch the IN.PACT Admiral
drug-eluting balloon in the United States during the second half of calendar
year 2015," said Tony Semedo, president of Medtronic's Endovascular Therapies
business. "In the meantime, we will continue working with leading healthcare
providers and researchers around the world to amass clinical and economic
evidence to support the global adoption of this innovative medical technology
as an important addition to the treatment options for peripheral artery
disease in the lower extremities."
The ongoing global clinical program o
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