Boston Scientific announced that the Centers for Medicare & Medicaid Services (CMS) has approved a New Technology Add-on Payment (NTAP) for its Agent™ drug-coated balloon (DCB).
The NTAP designation, effective from October 1, 2025, will provide additional reimbursement to hospitals using the Agent DCB in eligible inpatient cases. This move supports broader access to innovative technologies during their initial market rollout.
The Agent DCB is approved for the treatment of coronary in-stent restenosis (ISR) — a condition in which a previously stented artery becomes narrowed again due to plaque buildup or scar tissue. As a paclitaxel-coated balloon, Agent delivers a targeted dose of drug to the vessel wall to help prevent recurrence, offering an alternative to repeat angioplasty, further stenting, or radiation therapy.
Agent became the first FDA-approved drug-coated balloon for coronary use in the U.S. last year and is also available in multiple international markets. Over 100,000 patients globally have been treated with the technology.
“This CMS decision is a significant step forward for patients with ISR and further validates the clinical evidence showing Agent DCB outperforms traditional balloon angioplasty,” said Lance Bates, SVP of Interventional Cardiology Therapies at Boston Scientific. “The additional reimbursement will help hospitals provide broader access to this therapy for Medicare beneficiaries.”