FDA OKs First Drug-Coated Balloon for In-Stent Restenosis

The FDA has approved Boston Scientific’s Agent Drug-Coated Balloon (DCB) for the treatment of coronary in-stent restenosis in patients with coronary artery disease. The DCB transfers a therapeutic dose of the antiproliferative drug paclitaxel to the vessel wall to prevent restenosis. The approval was based on positive results from the AGENT IDE trial, which showed a 38% relative risk reduction in target lesion failure compared to conventional balloon angioplasty. The DCB also reduced rates of stent thrombosis and target-vessel related myocardial infarction. The device will be launched in the US soon, offering a new treatment option for in-stent restenosis.

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