Cordis today announced new findings from a duo of studies supporting the use of its Selution SLR drug-eluting balloon (DEB) system.
Miami Lakes, Florida-based Cordis announced results from the SELUTION DeNovo and SELUTION 4ISR trials at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Both randomized clinical trials demonstrated positive outcomes that met primary endpoints. Selution SLR performed in these studies against the standard of care in treating both de novo and in-stent restenosis (ISR) coronary lesions.
Cordis said the findings highlight Selution SLR as a compelling alternative to drug-eluting stents. It offers physicians the ability to minimize the need for the common stent offerings.
Selution SLR provides a controlled sustained drug release, similar to a drug-eluting stent. It features unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The micro-reservoirs provide a controlled and permanent release of the drug for up to 90 days. MedAlliance’s CAT (cell-adherent technology) allows microdeposits to coat the balloons and adhere to the vessel lumen when delivered through an angioplasty balloon.
The DEB is commercially available in more than 65 countries, but investigational in the U.S. Cordis acquired the DEB technology from MedAlliance for $1.135 billion in 2023.
More about the Selution SLR findings from Cordis
In the SELUTION DeNovo trial, investigators randomized 3,323 patients across 62 international sites. Cordis said it marked the largest randomized coronary DEB trial to date. It evaluated the DEB against the current standard of care, a systematic drug-eluting stent (DES) treatment strategy.
The company’s DEB treatment strategy demonstrated non-inferiority to a DES treatment strategy. Investigators reported 5.3% target vessel failure (TVF) at 12 months, compared to 4.4% in the DES arm. Evidence supports a Selution SLR strategy for de novo lesions as an alternative to DES, the company said.
In SELUTION4ISR, investigators looked at the DEB in patients with coronary ISR. It demonstrated non-inferior performance against ISR standard-of-care treatment, Cordis said.
TLF at 12 months came in at 15.2% compared to 13.5% in the standard of care arm, which included 80% using a DES. The company plans to use findings to support an FDA submission for a coronary ISR indication.
“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 Dr. Martin Leon, chair of the Cordis Clinical Advisory Board, professor of medicine at Columbia University Irving Medical Center & chief innovation officer and director of the Cardiovascular Data Science Center for the Division of Cardiology.
