Miami Lakes, Florida-based Cordis expects the SELUTION Global Coronary Registry to enroll up to 10,000 patients worldwide. It says that would make it one of the largest coronary DEB registries to date.
Investigators plan to track real-world outcomes of Selution SLR for up to five years, with findings complementing ongoing randomized trials. Cordis just last month presented positive 12-month results from the SUCCESS PTA study of the DEB. The company acquired the DEB technology from MedAlliance for $1.135 billion in 2023.
The SELUTION Global Coronary Registry builds upon five ongoing randomized trials. SUCCESS PTA most recently confirmed the sustained efficacy and safety of Selution SLR in treating complex peripheral artery disease (PAD). It proved effective and safe across diverse, real-world patient populations, according to a news release. The company said the balloon favorably matched best-in-class benchmarks from paclitaxel-eluting technologies, too.
“The history of Cordis is grounded in a commitment to clinical evidence; putting patients first means backing our technology with the strongest evidence we can provide. The launch of the SELUTION Global Coronary Registry reaffirms this commitment. We look forward to sharing groundbreaking coronary results this Fall,” said Dr. George Adams, chief medical officer at Cordis.