Cordis’ sirolimus-eluting balloon gets FDA approval for coronary in-stent restenosis

The U.S. FDA has approved Cordis’ SELUTION SLR™ 014 PTCA Drug-Eluting Balloon (DEB) for the treatment of coronary in-stent restenosis (ISR), giving interventional cardiologists a new sirolimus-based option for treating arteries that have narrowed again after stent placement.

The FDA approval covers use of the balloon following appropriate vessel preparation in patients undergoing PCI for ISR in coronary arteries measuring 2.25 to 4.50 mm in diameter and lesions up to 26 mm in length.

The approval is significant because the device delivers sirolimus through a balloon rather than leaving another permanent stent in the artery. According to Cordis, SELUTION SLR is the first and only sirolimus drug-eluting balloon currently approved in the U.S. for coronary use.

“The availability of SELUTION SLR™ DEB in the United States is meaningful for interventional cardiologists because it provides an effective and highly deliverable sirolimus-based treatment option while helping minimize the need for another stent. We are proud to help expand treatment choices in ways that can make a real difference in patient care,” said George Adams, MD, Chief Medical Officer, Cordis.

Why in-stent restenosis remains a challenge

In-stent restenosis occurs when a previously treated coronary artery becomes narrowed again within or around an implanted stent. It can develop because of tissue growth, inflammation or renewed plaque accumulation and can require another intervention.

Treating ISR can be particularly challenging because placing additional layers of stent is not always desirable. Drug-coated balloons provide another approach: the balloon temporarily contacts the vessel wall and delivers an antiproliferative drug without leaving a new permanent implant behind.

SELUTION SLR uses sirolimus, an antiproliferative drug already established in coronary drug-eluting stent technology. The device is designed to provide what Cordis calls Sustained Limus Release, with drug delivery intended to continue for up to 90 days.

What the FDA approval is based on

The approval was supported by the SELUTION4ISR trial, a prospective, multicenter, randomized, single-blind, controlled non-inferiority study comparing SELUTION SLR with standard of care in patients with coronary ISR.

The trial enrolled 418 patients across sites in the U.S., Europe, Canada and Latin America. Cordis reports that the study met its primary non-inferiority endpoint at 12 months. In the overall randomized population, target lesion failure occurred in 15.2% of patients treated with SELUTION SLR compared with 13.5% of those receiving standard of care.

The study is part of a broader clinical evidence base for the technology, with Cordis reporting data from more than 5,000 patients worldwide. The company’s clinical programme also includes studies investigating the balloon in de novo coronary lesions.

The FDA’s approval is specifically for ISR, however, rather than for all coronary lesions. This distinction is important as the company continues to evaluate the technology for additional indications.

What a drug-eluting balloon changes

Unlike a drug-eluting stent, a drug-eluting balloon does not leave a permanent metallic scaffold in the treated vessel. For patients with ISR, that distinction can be clinically relevant because the artery already contains a stent.

The approach therefore adds another tool to the interventional cardiologist’s options for managing recurrent narrowing. Rather than automatically adding another stent layer, physicians can consider a drug-delivery strategy in appropriate patients based on the characteristics of the lesion and the patient’s clinical circumstances.

The SELUTION SLR balloon has already been used in more than 250,000 patients globally and is commercially available in more than 65 countries, according to Cordis. The U.S. approval now brings its coronary ISR indication to the American market.

What’s next for SELUTION SLR?

Cordis is also studying SELUTION SLR for patients with de novo coronary lesions, meaning lesions that have not previously been treated with a stent.

Enrollment has been completed in the company’s 960-patient SELUTION 4DeNovo IDE trial, which is comparing the sirolimus-eluting balloon with drug-eluting stents in small coronary vessels. The study is intended to support a future FDA submission for that indication.

For now, the FDA approval is focused on coronary ISR. Its significance lies in adding a sirolimus-based drug-eluting balloon to the U.S. treatment landscape for patients whose coronary arteries have narrowed again following stent implantation.

For interventional cardiology, the development also reflects the broader movement toward treating coronary disease while limiting the amount of permanent material left behind in the vessel.

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