Cordis's SELUTION Balloon Data to Test Stent-Alternative Future

WASHINGTON, D.C. – March 04, 2026 – Global cardiovascular technology leader Cordis is set to present pivotal 12-month clinical data for its SELUTION SLR™ Drug-Eluting Balloon (DEB) at the upcoming Cardiovascular Research Technologies (CRT) 2026 conference. The presentations, scheduled for March 7-10, are highly anticipated by interventional cardiologists as they promise deeper insights into a technology that could offer a compelling alternative to permanent metal stents for treating coronary artery disease.

The data dump will feature outcomes from two major studies, SELUTION4ISR and SELUTION DeNovo, which have already demonstrated success in meeting their initial goals. This next wave of evidence is expected to further define the role of sirolimus-eluting balloons in treating both newly blocked arteries and the vexing problem of arteries re-narrowing inside a previously placed stent.

Building on Clinical Momentum

The upcoming presentations at CRT 2026 are not occurring in a vacuum. They build upon successful late-breaking trial results presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2025 conference, where both the SELUTION4ISR and SELUTION DeNovo trials met their primary endpoints against the current standard of care.

The SELUTION4ISR trial tackled the challenging issue of in-stent restenosis (ISR), a condition where a previously stented artery becomes blocked again. In the trial, the SELUTION SLR™ DEB proved to be non-inferior to a control group primarily treated with another drug-eluting stent. This result is significant because it suggests that physicians can treat ISR effectively by delivering medication via the balloon without implanting a new, permanent metal layer, a practice sometimes referred to as creating a "full metal jacket" that can complicate future treatment options.

Meanwhile, the SELUTION DeNovo trial, the largest randomized coronary DEB study to date with over 3,300 patients, evaluated a DEB-first strategy for de novo lesions—new blockages in arteries that have not been previously stented. The study found that a strategy using the SELUTION SLR™ DEB with provisional (as-needed) stenting was non-inferior to systematically implanting a drug-eluting stent. Remarkably, in this approach, approximately 80% of patients treated with the balloon did not require a stent implant, highlighting the potential for a "leave nothing behind" approach to become a mainstream reality.

“These presentations build on SELUTION4ISR and SELUTION DeNovo results presented at TCT, where both trials met their primary endpoints versus current standard of care,” said George Adams, MD, Chief Medical Officer at Cordis, in a recent statement. “Presentations at CRT provide additional insight into 12-month SELUTION outcomes and examine how procedural experience with drug-eluting balloon therapy influences clinical decision-making.”

The 'Leave Nothing Behind' Philosophy

At the heart of the excitement is the technology itself. The SELUTION SLR™ DEB is not just another balloon angioplasty device. It is coated with the drug sirolimus, which is delivered directly to the artery wall during a brief inflation. The balloon is then removed, leaving only the medication behind to prevent the vessel from re-narrowing.

This stands in contrast to drug-eluting stents, which are permanent metal scaffolds that remain in the body. While stents have revolutionized cardiology, they carry long-term risks, including a small but persistent risk of clot formation (stent thrombosis) and can make future interventions in the same vessel more difficult.

The SELUTION SLR™ features a unique Sustained Limus Release (SLR) technology, designed to provide a controlled and sustained release of sirolimus for up to 90 days. This extended duration is intended to cover the entire biological process of restenosis. The choice of sirolimus is also notable. While the first coronary DEB to gain U.S. approval uses paclitaxel, many experts believe sirolimus offers a wider therapeutic window and a more favorable long-term safety profile, aligning with the drug used on most modern drug-eluting stents.

This "leave nothing behind" philosophy is gaining traction among clinicians who see it as a way to restore vessel health without the long-term commitment and potential complications of a permanent implant. It preserves the natural vessel mechanics and keeps future treatment options open for patients, who are living longer and may require additional procedures over their lifetime.

Navigating the U.S. Regulatory Gauntlet

While the SELUTION SLR™ DEB is commercially available in over 65 countries, it remains an investigational device in the United States, the world's largest medical device market. The journey to U.S. approval is a rigorous and lengthy one, but Cordis has received signals of support from the Food and Drug Administration (FDA). The device was granted "breakthrough device designation," a status intended to expedite the review of technologies that could provide more effective treatment for life-threatening conditions.

Cordis is actively running pivotal IDE (Investigational Device Exemption) trials in the U.S. for both the in-stent restenosis and de novo lesion indications. The 12-month data being presented at CRT 2026 is a critical component of the evidence package being built to support a future Premarket Approval (PMA) submission to the FDA.

The competitive landscape, however, has recently been reshaped. In March 2024, Boston Scientific's AGENT™ Drug-Coated Balloon became the first and only DEB to receive FDA approval for treating coronary in-stent restenosis. While the AGENT balloon uses paclitaxel, its approval has validated the DEB concept for U.S. regulators and clinicians, potentially paving the way for other devices. The presence of an approved competitor raises the stakes for Cordis, which will need to demonstrate not just non-inferiority but potentially compelling advantages for its sirolimus-based platform to capture market share upon approval.

Beyond the Device: The Human Factor

Among the most intriguing presentations scheduled for CRT 2026 is a sub-study from the SELUTION DeNovo trial titled, "Operator Experience Effect on the Sirolimus-Eluting Balloon (SEB) Strategy." This analysis moves beyond the raw efficacy of the device to explore a critical real-world variable: the physician's learning curve.

Using a new technology like a DEB effectively requires specific techniques for lesion preparation and balloon deployment to ensure optimal drug transfer. This sub-study will shed light on how outcomes are influenced by a cardiologist's experience and proficiency with the DEB procedure.

According to one independent analyst not involved with the study, this type of research is vital. "We often see great results from pivotal trials run by expert super-users, but the real test is how a technology performs in the hands of the average community cardiologist," the analyst stated. "Understanding the learning curve is essential for developing effective training programs and ensuring that the benefits seen in trials can be replicated broadly, leading to consistent and safe patient outcomes."

This focus on the "human factor" demonstrates an evolving maturity in the field of medical device evaluation. It acknowledges that successful patient care is an interplay between innovative technology and skilled clinical practice. As the cardiology community gathers in Washington, the data from Cordis will be scrutinized not just for its clinical power, but for its practicality and its potential to be integrated safely and effectively into the everyday treatment of coronary artery disease. The sessions at CRT 2026 will therefore be a crucial forum for debate on how this promising technology will fit into the future of cardiovascular care.