AGENT™ Drug-Coated Balloon

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The heart continuously pumps blood through blood vessels, supplying the body with oxygen and nutrients. When these arteries narrow—especially inside a previously placed stent—it can reduce blood flow and cause symptoms like chest pain. In-stent restenosis (ISR) happens when tissue grows back inside the stent, leading to re-narrowing.

The Boston Scientific AGENT Drug-Coated Balloon (DCB) is a minimally invasive option designed to treat ISR without adding another stent. It delivers medication directly to the artery wall to help reduce tissue overgrowth and support better blood flow.

What Is AGENT Drug-Coated Balloon?

The AGENT Drug-Coated Balloon angioplasty is a medical device used to help treat coronary ISR. It’s a small, flexible balloon coated with a low dose of the medication paclitaxel and a helper ingredient called ATBC that helps the medicine stay where it's needed.

This coating helps the drug stick to and stay in the artery wall where it’s needed—while limiting how much of the drug enters the bloodstream and spreads to other parts of the body. During a minimally invasive procedure, the balloon is guided to the narrowed section of the artery. Once in place:

The balloon is inflated, which gently presses against the arterial wall and helps open narrowed arteries.
As it inflates, the balloon transfers paclitaxel directly into the vessel wall. This medication works by slowing down cell growth, which can lead to re-narrowing.
No new stent is left behind—just the medication delivered to the site.

This approach provides an option for patients with ISR who need or benefit from another metal stent placement may not. It’s been evaluated in clinical trials and is now FDA-approved for use in the United States specifically for ISR treatment.

What To Expect During a DCB Procedure?

If your doctor recommends the AGENT DCB procedure to treat ISR, it may help to understand what the experience typically involves.

Before the Procedure

Your care team will explain the process and review your medical history to ensure this treatment is right for you. Some patients may undergo pre-dilation, a step where the narrowed area is first gently opened using a standard balloon or another tool to prepare the vessel. This helps ensure the drug from the AGENT balloon can be delivered effectively.

In some cases, your doctor may use imaging tools inside blocked arteries to better understand the condition of the vessel before and during the procedure. You’ll also receive instructions about medications, such as aspirin and a P2Y12 inhibitor, which are typically started before the procedure and may be continued for a period afterward.

During the Procedure

The procedure is done using percutaneous coronary intervention (PCI), a minimally invasive approach:

A thin tube (catheter) is inserted through an artery, often in the wrist or groin and guided to the heart.
The AGENT DCB is positioned at the site of the previously placed stent where narrowing has occurred.
The balloon is then inflated, delivering a small dose of the medication paclitaxel directly into the vessel wall.
Once the medication is delivered, the balloon is removed. No permanent implant is left behind.

After the Procedure

Afterward, you’ll be monitored to ensure your recovery is well. Depending on your doctor's guidance, you may continue to take dual antiplatelet therapy (DAPT) for a period. Follow-up visits are important. These may include clinical checkups and possibly imaging to assess how your artery is healing and whether the treatment has been effective. In clinical studies, many patients were followed for at least 12 months to track outcomes.

Benefits of Minimally Invasive Vascular Treatments

Here’s how AGENT Drug-Coated Balloon may support improved patient outcomes:

Treatment Without Adding Another Stent

When ISR occurs, placing a second or third stent may not always be ideal. AGENT DCB treats the narrowed area by delivering medication directly to the artery wall without leaving a new stent behind. This may help maintain space in the vessel and avoid additional metal layers.

Local Drug Delivery To Target Overgrowth

AGENT DCB uses a balloon coated with paclitaxel, a drug that helps slow the overgrowth of tissue that causes restenosis. This drug is transferred to the artery wall when the balloon is inflated during the procedure.

Preservation of Artery Anatomy

ains in the artery, its natural shape and movement are preserved. This may be especially important in smaller or more delicate blood vessels, where space is limited.

Support for Quality of Life

In clinical follow-ups, many patients reported feeling better after their procedure. Improvements in health status were seen shortly after treatment and remained stable through one year in studies of AGENT.