FDA Approved Cordis Drug-Coated Balloon Catheter
The regulatory approval marks the U.S. market entry for the only sirolimus-coated balloon available to patients.
Updated on Oct. 12, 2026 in Heart Disease
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The FDA has granted approval for the Cordis Selution drug-coated balloon catheter. This medical device is designed to treat narrowed arteries by delivering medication directly to the artery wall without requiring a permanent metallic stent.
Why it matters
By eliminating the need for a permanent metal implant, the device offers an alternative treatment for arterial narrowing. It utilizes sirolimus to prevent vessels from constricting again after the initial procedure.
The device is the only sirolimus-coated balloon approved in the U.S. and is manufactured at Cordis facilities covering 76,000 square feet in Irvine, California.
The players
FDA
The United States Food and Drug Administration is the federal agency responsible for regulating medical devices and ensuring patient safety.
Cordis
Cordis is a medical device manufacturer headquartered in Miami Lakes, Florida, that operates in over 65 countries.
Dr. William Murphy Jr.
Dr. William Murphy Jr. was the original founder of the medical device company Cordis in 1957.
The details
The Selution catheter functions by delivering medication directly to the site of an arterial blockage to manage long-term vessel patency. This approach avoids the complications associated with the placement of permanent metal stents.
Timeline
1957 marks the founding of Cordis by Dr. William Murphy Jr.
1996 saw Johnson & Johnson acquire Cordis for $1.8 billion.
2004 was when the company commercialized its first drug-eluting stent.
2015 was the year Cardinal Health purchased the company.
2021 marked the acquisition of Cordis by Hellman & Friedman.
Health Landscape
The Selution catheter marks a departure from the drug-eluting stent technology the company commercialized in 2004. This shift moves the industry toward temporary treatment solutions that avoid the long-term placement of permanent metal implants in patients.
Patients may now have access to a new treatment option that avoids the use of permanent metallic stents during arterial procedures. This development provides a path for managing narrowed arteries using localized medication delivery.
The takeaway
This technology provides a specialized alternative for managing arterial narrowing without the permanence of older stent designs. Patients should discuss with their physicians whether balloon-based drug delivery is a viable option for their specific vascular health needs.
Further reading
For more information on current treatment options, visit the Heart Disease section.
Source note: This article includes information reported by Orange County Business Journal.
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