Medical Device Innovation

New PMA approval introduces a sirolimus-eluting balloon treatment for coronary arteries, supported by randomized clinical evidence and ongoing post-approval surveillance.

FDA approved the SELUTION SLR™ 014 PTCA Drug-Eluting Balloon on September 18, 2026, authorizing commercial distribution under the conditions specified in its approval order.

The device received FDA Breakthrough Device designation in February 2019, although the FDA PMA database indicates that expedited review was not granted.

FDA Authorization

Device Overview

The SELUTION SLR is a drug-eluting balloon catheter used to treat coronary in-stent restenosis (ISR), a condition in which an artery becomes narrowed again following the placement of a coronary stent.

During percutaneous coronary intervention (PCI), the balloon is positioned within the narrowed portion of the artery and inflated to restore blood flow. At the same time, it delivers sirolimus, a medication intended to inhibit the tissue growth that can cause the artery to narrow again.

FDA approved the device for use after appropriate vessel preparation in coronary arteries measuring 2.25–4.50 mm in diameter, with lesions no longer than 26 mm.

Unlike the placement of another coronary stent, treatment with a drug-eluting balloon does not leave an additional permanent implant in the artery.

Technology and Innovation

The SELUTION SLR combines conventional balloon angioplasty with a specialized drug-delivery coating designed to provide sustained release of sirolimus.

Its coating incorporates sirolimus within biodegradable polymer microspheres, together with a lipid-based formulation that facilitates drug transfer to the vessel wall during balloon inflation.

The microspheres are designed to regulate the release of sirolimus as the polymer gradually degrades.

This approach offers an alternative to implanting another drug-eluting stent, particularly when additional layers of stent material may be undesirable.

The technology is an example of continued innovation in drug-device combination products, combining mechanical intervention with localized pharmaceutical therapy.

Clinical Evidence

FDA approval was supported by the SELUTION4ISR clinical study, a prospective, multicenter, randomized trial involving 418 patients with coronary in-stent restenosis.

The study compared SELUTION SLR with standard-of-care treatment consisting primarily of drug-eluting stents, with conventional balloon angioplasty also permitted.

The primary endpoint was target lesion failure at 12 months, a composite measure incorporating cardiac death, target-vessel myocardial infarction, and the need for repeat treatment of the target lesion.

The study met its primary endpoint, demonstrating noninferiority to standard-of-care treatment.

However, a prespecified secondary comparison involving patients with one previous stent layer did not demonstrate noninferiority to treatment with an additional drug-eluting stent. Target lesion failure was 14.2% with SELUTION SLR versus 6.5% in the drug-eluting stent comparison group.

FDA noted limitations in interpreting this secondary comparison because patients receiving the different standard-of-care treatments were not separately randomized.

These findings suggest that patient selection is important, particularly when considering whether an additional stent is clinically appropriate.

Regulatory Significance

Several aspects of the approval are noteworthy for medical device manufacturers and regulatory professionals.

Breakthrough Device designation. FDA granted the device Breakthrough Device designation in 2019, recognizing the potential importance of the technology and its proposed clinical application.

Combination product requirements. The device incorporates both mechanical and pharmaceutical functions, requiring supporting evidence related to device performance, drug delivery, biocompatibility, and product stability.

Post-approval clinical follow-up. FDA required continued monitoring of the 418 patients enrolled in the pivotal SELUTION4ISR study through five years following treatment.

Real-world surveillance. A separate post-approval surveillance analysis will evaluate approximately 3,500 patients treated at U.S. sites, with particular attention to outcomes among women and racial and ethnic groups underrepresented in the pivotal clinical study.

Product stability requirements. The approval includes additional long-term drug stability testing and evaluation of the sirolimus coating. FDA established an approved shelf life of 18 months.

These requirements illustrate how PMA approval can extend beyond the initial authorization decision, with continuing obligations to evaluate long-term clinical performance, product quality, and real-world safety.

Editorial note

One feature of this approval deserves particular attention: the pivotal study met its primary noninferiority endpoint, but a prespecified secondary comparison did not. Both findings are important to understanding the clinical evidence. The FDA’s SSED reports 16.2% versus 14.5% target lesion failure for the primary comparison and 14.2% versus 6.5% for the secondary comparison involving one previous stent layer.

Source: U.S. Food and Drug Administration, PMA P250041. MDP Regulatory Intelligence — September 2026 Market Authorizations.