Cordis has announced results from the SELUTION DeNovo and SELUTION4ISR trials, presented during a late-breaking trials session at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–28 October, San Francisco, USA).
Both randomised clinical trials demonstrated positive outcomes that met primary endpoints for the Selution SLR drug-eluting balloon (DEB) compared to the current standard of care in treating de novo and in-stent restenosis (ISR) coronary lesions. The results highlight Selution as an alternative to drug-eluting stents (DES), offering physicians the ability to minimise the need for stents, the company said in a press release highlighting the results.
In the SELUTION DeNovo trial, a Selution SLR treatment strategy was compared in real-world coronary de novo lesions was compared to the current standard of care, a systematic DES treatment strategy. With 3,323 patients enrolled across 62 international sites, it is the largest randomised coronary DEB trial to date.
The Selution SLR DEB treatment strategy demonstrated non-inferiority to a DES treatment strategy with target vessel failure (TVF) at 12-months of 5.3% as compared to the DES arm with 4.4%.
“These findings signal a paradigm shift in how we approach percutaneous coronary intervention,” said co-principal investigator Christian Spaulding (Hôpital Européen Georges-Pompidou, Paris, France). “Selution SLR DEB achieved results comparable to drug-eluting stents while reducing the need for stents. With this minimal stenting approach, patients can benefit from an effective and safe sirolimus drug-eluting balloon treatment today, while keeping more options available for tomorrow.”
The SELUTION4ISR trial, a prospective, multicentre, randomised controlled study evaluating Selution SLR DEB in patients with coronary in-stent restenosis, demonstrated non-inferior performance against standard-of-care treatment.
Target lesion failure (TLF) at 12-months was 15.2% with the DEB vs. 13.5% in standard of care control which was comprised of 80% DES. These results will be leveraged to support a submission to US Food and Drug Administration (FDA) for coronary ISR indication of the device.
“With the sirolimus-based Selution SLR DEB, clinicians now have a proven option that delivers durable efficacy while avoiding additional metal layers and the long-term challenges they pose in treating ISR,” said co-principal Investigator, Roxana Mehran (Icahn School of Medicine at Mount Sinai, New York, USA).
“I applaud Cordis for again moving the coronary interventional field forward with the successful SELUTION DeNovo and SELUTION4ISR trials. These trials demonstrate safe and efficacious results for SELUTION SLR DEB in treating complex de novo and ISR lesions, providing a real alternative to a DES,” said Martin Leon (Columbia University Irving Medical Center, New York, USA), chair of the Cordis clinical advisory board.
