Boston Scientific gets FDA approval for drug-coated balloon catheter

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Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Agent drug-coated balloon, a paclitaxel-coated balloon catheter sized to fit within blocked or constricted coronary arteries to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.

ISR is the obstruction or narrowing of a stented vessel due to scar tissue or plaque; approximately 10% of percutaneous coronary interventions in the U.S. are due to ISR. As an alternative to traditional therapies such as balloon angioplasty, additional layers of stenting or radiation, the Agent device works by inflating to reopen the stent and delivers a therapeutic dose of paclitaxel to the vessel wall to help reduce the risk of recurrence.

The Agent balloon received the CE Mark in 2014 and is currently available in Europe, parts of Asia Pacific, and Latin America for the treatment of patients with ISR and previously untreated small vessel coronary disease.

The Agent balloon received breakthrough device designation by the FDA in 2021; its approval was supported by positive results from the AGENT IDE trial, which enrolled 600 patients at 40 U.S. sites.

In a statement, Boston Scientific said that it plans to launch the technology in the U.S. in the upcoming months.

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