What's Happening?
Cordis has unveiled groundbreaking results from the SELUTION DeNovo and SELUTION4ISR trials at the TCT 2025 symposium. The trials demonstrated that the SELUTION SLR Drug-Eluting Balloon (DEB) is a viable alternative to drug-eluting stents (DES) for treating
coronary artery disease. The SELUTION DeNovo trial, involving 3,323 patients, showed non-inferiority of the DEB strategy compared to DES in de novo lesions. The SELUTION4ISR trial confirmed the DEB's non-inferiority in treating in-stent restenosis. These findings suggest a shift towards minimal stenting approaches, offering effective treatment while preserving future options for patients.
Why It's Important?
The results from these trials could significantly impact the treatment landscape for coronary artery disease. By providing an alternative to traditional stenting, the SELUTION SLR DEB could reduce the need for metal implants, potentially lowering the risk of long-term complications associated with stents. This innovation aligns with a growing trend towards less invasive and more flexible treatment options in cardiovascular care. For Cordis, these findings reinforce its position as a leader in cardiovascular innovation and could lead to increased adoption of its DEB technology, expanding its market presence.
What's Next?
Cordis plans to leverage the trial results to support a submission to the FDA for the coronary ISR indication of the SELUTION SLR DEB. If approved, this could pave the way for broader use of DEB technology in the U.S. market. The company is likely to continue clinical investigations to further validate the efficacy and safety of its DEB technology, potentially exploring additional indications or patient populations. The positive trial outcomes may also prompt healthcare providers to reconsider current treatment protocols, integrating DEB as a standard option for coronary interventions.
