FDA Expands Access to Drug-Eluting Balloons
The federal agency approved the SELUTION SLR device on September 18, 2026, for treating coronary in-stent restenosis.
Updated on Oct. 21, 2026 in Heart Disease
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On September 18, 2026, the FDA approved the SELUTION SLR drug-eluting balloon, expanding the available technologies for treating in-stent restenosis in the United States. This device provides a new option for managing vessel re-narrowing without the need for an additional metal stent.
Why it matters
These specialized balloons allow physicians to manage the underlying causes of restenosis while minimizing the need for multiple repeat procedures. The availability of diverse drug-eluting options improves outcomes for patients who have hypersensitivity to specific coatings or complex vessel anatomy.
The AGENT IDE trial included 600 participants and demonstrated a 28% relative reduction in target lesion failure at three years. The AGENT device is specifically indicated for vessels exceeding a 4.0 mm diameter threshold.
The players
Food and Drug Administration
The federal agency is responsible for protecting public health by ensuring the safety and effectiveness of medical devices and medications.
Boston Scientific
The medical technology company is the manufacturer responsible for the AGENT coronary drug-coated balloon and its ongoing clinical trials.
Society for Cardiovascular Angiography and Interventions
This professional medical society provides standards and clinical guidance for interventional cardiologists.
The details
The technology works by delivering drugs like paclitaxel directly to the vessel wall, inhibiting cell proliferation that leads to restenosis. While AGENT utilizes paclitaxel to manage vessel re-narrowing, other devices utilize sirolimus to inhibit cell growth through the mTOR pathway.
Timeline
2023: The Society for Cardiovascular Angiography and Interventions published a consensus statement on managing in-stent restenosis.
February 29, 2024: The FDA granted approval for the AGENT paclitaxel-coated balloon.
September 18, 2026: The FDA approved the SELUTION SLR drug-eluting balloon for United States market use.
The Big Picture
The approval of these devices follows the FDA Breakthrough Device designation, which is intended to expedite the clinical availability of technologies that provide more effective treatment for serious conditions. This regulatory pathway marks a shift toward prioritizing specialized, minimally invasive cardiovascular tools over legacy metal-stent procedures.
Patients may now have access to a broader range of balloon technologies that reduce the likelihood of requiring repeated coronary procedures. Clinicians can select between paclitaxel-coated or sirolimus-based options based on individual patient hypersensitivities and specific vessel anatomy.
The takeaway
The move toward drug-coated balloon therapy represents a significant shift in interventional cardiology toward device-agnostic vessel management. Patients with a history of restenosis should discuss the availability of these specific device coatings with their cardiology teams to determine the best treatment path.
Further reading
Learn more about advancements in cardiovascular care by visiting the Heart Disease section.
More information
Access detailed regulatory documentation for these technologies through the FDA device approval database.
Source note: This article includes information reported by DAIC.
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