Drug-Coated Balloons Offer New Treatment for Heart Patients
These FDA-approved devices help patients with recurring arterial blockage by reducing the need for new metal stents.
Updated on Oct. 21, 2026 in Heart Disease
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The FDA recently expanded treatment options for coronary in-stent restenosis by approving the SELUTION SLR drug-eluting balloon on September 18, 2026. This technology joins the AGENT paclitaxel-coated balloon as a new therapeutic choice for patients managing recurring vessel blockage.
Why it matters
These drug-coated balloons provide an alternative to traditional procedures by delivering medication directly to the vessel wall without requiring a new metal stent. This approach aims to address the root cause of restenosis and potentially reduce the need for future interventions in eligible patients.
In a 600-patient randomized IDE trial, the AGENT device demonstrated a 17.9% target lesion failure rate at one year compared to 28.6% in the control group. Long-term follow-up indicates a 28% relative reduction in target lesion failure at three years for the treatment arm.
The players
FDA
The federal agency responsible for regulating medical devices and ensuring the safety and efficacy of new treatments in the United States.
Boston Scientific
A global medical device manufacturer specializing in cardiovascular intervention technologies and the developer of the AGENT balloon.
SCAI
The Society for Cardiovascular Angiography and Interventions is a professional organization that provides expert guidance on cardiac procedures.
The details
The AGENT balloon delivers paclitaxel directly to the vessel wall to inhibit cell proliferation, while the newly approved SELUTION SLR uses sirolimus to modulate the mTOR pathway. By applying these medications locally, clinicians can manage tissue regrowth without the risks associated with implanting multiple layers of metal stents. SELUTION SLR specifically offers a path for patients with paclitaxel hypersensitivity or complex cases involving vessels larger than 4.0 mm.
Timeline
2023: SCAI published an expert consensus statement on managing in-stent restenosis.
February 29, 2024: The FDA approved the AGENT paclitaxel-coated balloon.
September 18, 2026: The FDA approved the SELUTION SLR drug-eluting balloon.
Health Landscape
The introduction of these drug-coated balloons marks a strategic shift away from repeated stenting to manage vessel blockage. These technologies reflect a broader trend in interventional cardiology toward utilizing site-specific medication delivery to reduce long-term device burden.
Patients with recurring coronary artery narrowing may now have options beyond traditional repeat stenting or plain balloon angioplasty. These advancements are worth discussing with your cardiologist to understand if you are a candidate based on your specific vessel characteristics and medical history.
The takeaway
Drug-coated balloons represent a significant evolution in treating narrowed coronary arteries without the need for additional permanent metal implants. If you have a history of in-stent restenosis, talk to your doctor about whether these new device technologies align with your personal care plan.
Further reading
For more on evolving care standards, see the Heart Disease section.
More information
Review the full FDA device approval database for additional regulatory details.
Source note: This article includes information reported by DAIC.
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