Boston Scientific's AGENT Drug-Coated Balloon receives FDA approval for treating coronary in-stent restenosis in patients with coronary artery disease.
Boston Scientific received FDA approval for its AGENT™ Drug-Coated Balloon (DCB) to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease. The AGENT DCB is designed as an alternative to balloon angioplasty, additional layers of stenting, and radiation, and aims to prevent in-stent restenosis reoccurrence. The approval was supported by the positive results of the AGENT IDE trial, which demonstrated the AGENT DCB's effectiveness and safety in treating ISR. Boston Scientific plans to launch the technology in the U.S. in the coming months.
March 01, 2024
11 Articles