Cordis has announced the initiation of the SELUTION global coronary registry, a prospective study enrolling up to 10,000 patients worldwide, assessing the company’s Selution SLR coronary drug-coated balloon (DCB).
The registry will track real-world outcomes of the device for up to five years and will complement the results from the on-going randomised trials.
The SELUTION global coronary registry builds upon the five ongoing level 1 randomised trials and the recently reported positive peripheral experience which showed competitive and durable results, the company says in a press release.
“Drug-eluting balloons are one of the most interesting and exciting new technologies in the coronary interventional space,” said Ajay J Kirtane (Columbia University Irving Medical Center, New York, USA). “The creation and initiation of this large real-world registry examining drug-eluting balloon utilisation and the practice of percutaneous coronary intervention (PCI) with this technology is a welcome development, which will help clinicians better understand where SELUTION SLR drug-eluting balloon can deliver the greatest benefits and improved outcomes in their practice.”
The steering committee for the registry includes Kirtane, alongside Alexandre Abizaid (Universidade de Sao Paulo, Sao Paulo, Brazil), Robert Byrne (RCSI University, Dublin, Ireland), Nieves Gonzalo (Hospital Clinico San Carlos, Madrid, Spain) and Robert Yeh (Beth Israel Deaconess Medical Center, Boston, USA).
“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 George Adams, chief medical officer at Cordis.
