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BioWorld - Saturday, April 11, 2026
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Home » FDA approves ‘needle-moving’ Boston Scientific’s Agent balloon
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FDA approves ‘needle-moving’ Boston Scientific’s Agent balloon

March 1, 2024
By Annette Boyle
On March 1, Boston Scientific Corp.’s Agent drug-coated balloon (DCB) became the first DCB to gain U.S. FDA approval for treatment of in-stent restenosis in patients with coronary artery disease. With more than 100,000 patients already treated in Europe, Latin America and Japan, it’s no secret Agent provides significant benefit compared to balloon angioplasty or drug-eluting stents (DES) for the approximately 10% of patients with coronary stents who experience subsequent narrowing of the treated vessel.
Medical technology Regulatory Cardiovascular Asia-Pacific Japan U.S. FDA PMA

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