Medtronic Issues First PMA Module for IN.PACT Balloon
Marking a major milestone in the advancement of new treatments for peripheral artery disease, Medtronic, Inc. (NYSE: 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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