Fierce Biotech March 1, 2024
Boston Scientific has received FDA approval for its Agent drug-coated balloon sized to fit within blocked or constricted coronary arteries, nearly a decade after it made its European debut.
The company said the green light makes the paclitaxel-equipped device the first of its kind in the U.S. for the treatment of coronary in-stent restenosis, where the path cleared by a previously placed heart stent has been overtaken by plaque or scar tissue.
Boston Scientific estimates that in-stent restenosis drives about 10% of all percutaneous coronary procedures in the U.S. and says the addition of a dose of paclitaxel to the blood vessels’ walls can help prevent its reoccurrence.
The company previously obtained a CE mark in Europe for the...
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