Selution SLR

SELUTION SLR Drug-Eluting Balloon (DEB) Clinical Studies

Cordis Announces Groundbreaking Results of SELUTION DeNovo and SELUTION4ISR Randomized Trials that Move Coronary Artery Disease (CAD) Treatment Beyond Stenting at TCT 2025

• The SELUTION DeNovo Study: This is the largest randomized Drug Eluting Balloon (DEB) study to date, evaluating the SELUTION SLR™ DEB strategy. de novo According to the Drug Eluting Stent (DES) strategy in lesions. non-inferior he has proved (that he does not stay down).

• SELUTION4ISR Study: This randomized controlled study has demonstrated that SELUTION SLR™ DEB is an alternative to current standard of care methods in the treatment of In-Stent Restenosis (ISR).

Miami Lakes, FL – October 26, 2025 – A global leader in cardiovascular interventional technologies. Cordis, today announced the groundbreaking results of the SELUTION DeNovo and SELUTION4ISR studies at the annual scientific symposium Transcatheter Cardiovascular Therapeutics® (TCT®) 2025 organized by the Cardiovascular Research Foundation® (CRF®).

Both randomized clinical studies demonstrated that the SELUTION SLR™ Drug Eluting Balloon (DEB), de novo and has shown that it exhibits positive results that meet the primary endpoints in the treatment of ISR coronary lesions compared to the current standard of care. These results offer physicians the opportunity to minimize the need for stents, making the SELUTION SLR™ DEB stand out as a convincing alternative to drug-release stents (DES).

SELUTION DeNovo Study: Non-Inferiority Demonstrated Against DES Strategy in 3,323 Patients at 62 Centers

In the highly anticipated SELUTION DeNovo study, real-world coronary de novo The SELUTION SLR™ DEB strategy applied to lesions was compared with the systematic DES strategy, which is the current standard of care. This study involved 3,323 patients across 62 international centers. The largest randomized coronary DEB study conducted to date. It possesses the characteristic of being...

• Result: The SELUTION SLR™ DEB strategy showed non-inferiority (non-inferiority) at 12-month Target Vascular Insufficiency (TVF) rates of 5.3% versus 4.4% in the DES group. These data are, de novo The lesions support that the SELUTION SLR™ DEB strategy is an alternative to traditional DES treatment.

"These findings indicate a paradigm shift in our Percutaneous Coronary Intervention (PCI) approach," said Principal Investigator from Paris Hôpital Européen Georges-Pompidou. Professor Christian Spaulding. "SELUTION SLR™ DEB achieved results comparable to drug-eluting stents while reducing the need for stents." With this minimal stenting approach, patients benefit from an effective and safe sirolimus-eluting balloon treatment today while retaining more options for the future.”

SELUTION4ISR Study: Study Conducted at Global Centers Confirmed Compliance with Standard Care

SELUTION4ISR, a prospective, multicenter, randomized controlled trial evaluating SELUTION™ SLR DEB in patients with intra-coronary stent restenosis (ISR), demonstrated non-inferior performance versus ISR standard of care therapy.

• Result: the 12-month Target Lesion Failure (TLF) was realized as 15.2% with SELUTION SLR™ DEB compared to 13.5% in the standard care control group, 80% of which consisted of DES. These results will be used in the FDA approval process for the device's coronary ISR indication.

Principal Investigator from Mount Sinai Medical School, New York Dr. Roxana Mehran"”With the Sirolimus-based SELUTION SLR™ DEB, clinicians now have a proven option that provides lasting efficacy while avoiding additional layers of metal in the treatment of ISR and the long-term challenges they pose," he said. October 19, 2011.

Looking to the Future and Cordis' Vision

These two studies presented at TCT® represent Cordis' commitment to innovation in cardiovascular interventions. Having reached the primary endpoints in both SELUTION4ISR and SELUTION DeNovo studies, Cordis is preparing to pioneer the widespread use of drug-release balloons in PCI treatment strategies.

Chair of the Cordis Clinical Advisory Board and Faculty Member at Columbia University Medical Center Dr. Martin Leon He added the following: “I applaud Cordis for advancing the coronary interventional field with the successful SELUTION DeNovo and SELUTION4ISR studies. These studies demonstrate the complex nature of SELUTION SLR™ DEB. de novo and it proves to offer safe and effective results in the treatment of ISR lesions and provides a genuine alternative to DES.”

About SELUTION SLR™ DEB

SELUTION SLR™ DEB, which is commercially available in over 65 countries and is under investigation in the USA, Sustained Limus Release (SLR) It stands out with its technology. This technology is designed to provide controlled and sustained drug release for 90 days to cover the restenosis cascade.