FDA Approved New Sirolimus-Coated Balloon Catheter

The newly cleared device treats narrowed arteries without the need for a permanent metallic implant.

Updated on Oct. 12, 2026 in Heart Disease

FDA Approved New Sirolimus-Coated Balloon Catheter

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The FDA has approved the Cordis Selution drug-coated balloon catheter for use in the United States. This device offers a new option for patients with narrowed arteries by providing treatment without leaving behind a permanent stent.

Why it matters

The technology aims to prevent arteries from re-narrowing after treatment. By using sirolimus, the device targets the vessel wall directly to improve long-term outcomes for patients with cardiovascular disease.

The FDA approved the Selution catheter, the only sirolimus-coated balloon currently cleared in the U.S. clinical market. While data indicates a 5% re-narrowing risk at one year, rates climb to 12% at five years and 18% within ten years.

The players

FDA

The federal agency responsible for evaluating the safety and efficacy of medical devices and pharmaceuticals.

Cordis

A medical device company specializing in cardiovascular technologies and peripheral vascular disease solutions.

Dr. William Murphy Jr.

The founder of Cordis who established the company in 1957.

The details

The balloon catheter functions by delivering medication directly to the wall of a narrowed artery. Because it relies on a drug-coated balloon rather than a permanent metallic stent, it treats the obstruction without leaving hardware behind in the vessel. The device is manufactured in a 76,000-square-foot facility in Irvine, California, to ensure its specific coating remains stable for patient use.

1957: Cordis was founded by Dr. William Murphy Jr.
1996: Johnson & Johnson acquired Cordis for $1.8 billion.
2004: Cordis commercialized the first drug-eluting stent.
2015: Cardinal Health purchased the company.
2021: Hellman & Friedman acquired Cordis.

Health Landscape

This approval marks a significant shift away from the drug-eluting stent paradigm by providing localized medication delivery without the requirement of a permanent metal implant. It represents an evolution in interventional cardiology toward temporary, drug-based mechanical interventions.

If you are undergoing procedures for narrowed arteries, this device offers an alternative to permanent metallic implants that is worth discussing with your doctor. Understanding your specific risk of re-narrowing is a key part of long-term cardiovascular management.

The takeaway

The arrival of this sirolimus-coated balloon provides a stent-free option for clearing narrowed arteries. Patients should consult their cardiologist about whether this device is a suitable alternative given their unique vascular history and long-term health goals.