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Boston Scientific earns Medicare reimbursement for Agent drug-coated balloon

August 1, 2025 By Sean Whooley

Boston Scientific Agent drug-coated balloon DCB
The Agent drug-coated balloon. [Image from Boston Scientific]

Boston Scientific (NYSE: BSX) announced today that CMS granted reimbursement for its Agent drug-coated balloon (DCB).

CMS granted a new technology add-on payment (NTAP) for eligible cases using Agent.

NTAP provides additional reimbursement to hospitals that use designated new medical technologies in the first few years of market introduction. Starting Oct. 1, 2025, CMS intends to provide hospitals with additional device reimbursement when the Agent DCB is used for eligible cases in the hospital inpatient setting.

Agent treats coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. It serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation. The paclitaxel-coated balloon transfers a therapeutic dose of drug to the vessel wall, helping to prevent ISR recurrence.

Boston Scientific won FDA approval for Agent last year, making it the first drug-coated coronary balloon available in the U.S. The company also offers it commercially in several international markets, with more than 100,000 patients treated with Agent globally.

“The CMS determination is a positive development for patients with in-stent restenosis and supports clinical findings that the Agent DCB is statistically superior to conventional balloon angioplasty for treating the condition,” said Lance Bates, SVP, Interventional Cardiology Therapies, Boston Scientific. “We applaud this ruling as it will allow hospitals to receive additional reimbursement when treating patients with the device, supporting access to the Agent DCB for Medicare beneficiaries.”

Filed Under: Applications, Balloons, Business, Cardiology, Catheters, Technologies & Devices Tagged With: Boston Scientific, Centers for Medicare and Medicaid Services (CMS), CMS

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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