Sam Brusco, Associate Editor03.01.24
Boston Scientific has earned U.S. Food and Drug Administration (FDA) approval for its Agent drug-coated balloon (DCB) to treat coronary in-stent restenosis (ISR) for coronary disease patients.
Agent DCB is an alternative to traditional therapies like balloon angioplasty, additional layers of stenting, or radiation. The paclitaxel-coated balloon catheter transfers a therapeutic dose of drug to the vessel wall to help prevent recurrence of ISR.
The technology was granted breakthrough status by the FDA in 2021. The AGENT IDE trial met its primary endpoint of target lesion failure at 12 months—the Agent DCB showed statistical superiority to uncoated balloon angioplasty (17.9% vs. 28.7%). Findings also showed no definite/probable cases of clotting in the stent, 49% less risk of heart attack at the at target vessel, and low adverse event rates.
Agent DCB is now available in Europe, parts of Asia Pacific, and Latin America to treat ISR and previously untreated small vessel coronary disease. Boston Scientific plans to launch it in the U.S. in the coming months.
“With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the U.S,” said Lance Bates, president, Interventional Cardiology Therapies, Boston Scientific. “The AGENT DCB addresses a critical unmet need by providing a dedicated treatment option for the challenging condition of ISR and we look forward to offering U.S. physicians the opportunity to treat their patients with this novel device.”
Agent DCB is an alternative to traditional therapies like balloon angioplasty, additional layers of stenting, or radiation. The paclitaxel-coated balloon catheter transfers a therapeutic dose of drug to the vessel wall to help prevent recurrence of ISR.
The technology was granted breakthrough status by the FDA in 2021. The AGENT IDE trial met its primary endpoint of target lesion failure at 12 months—the Agent DCB showed statistical superiority to uncoated balloon angioplasty (17.9% vs. 28.7%). Findings also showed no definite/probable cases of clotting in the stent, 49% less risk of heart attack at the at target vessel, and low adverse event rates.
Agent DCB is now available in Europe, parts of Asia Pacific, and Latin America to treat ISR and previously untreated small vessel coronary disease. Boston Scientific plans to launch it in the U.S. in the coming months.
“With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the U.S,” said Lance Bates, president, Interventional Cardiology Therapies, Boston Scientific. “The AGENT DCB addresses a critical unmet need by providing a dedicated treatment option for the challenging condition of ISR and we look forward to offering U.S. physicians the opportunity to treat their patients with this novel device.”