Cordis SELUTION4DeNovo DEB IDE Trial Begins Enrollment

November 6, 2023—Cordis recently announced that the first patient was enrolled in its SELUTION4DeNovo trial. Conditional FDA investigational device exemption (IDE) approval for the study was announced in January 2023.

According to Cordis, SELUTION4DeNovo is a prospective, multicenter, single-blind, randomized controlled trial that is designed to demonstrate the safety and efficacy of the company’s Selution SLR sirolimus drug-eluting balloon (DEB) for the percutaneous coronary intervention (PCI) treatment of de novo lesions in small coronary vessels. On October 2, Cordis completed its acquisition of MedAlliance, manufacturer of the Selution SLR.

The study will randomize up to 910 patients and will enroll up to 30 patients in a parallel angiographic substudy and up to 20 patients in a parallel pharmacokinetic substudy. Patients will be enrolled at up to 80 sites in the United States, Canada, Brazil, Japan, and Europe. A minimum of 50% of patients will be enrolled in the United States.

The Principal Investigator of the study is Ron Waksman, MD, who serves as Chairman of the MedAlliance Coronary Study Steering Committee. Dr. Waksman is Professor of Cardiology at Georgetown University and Director of Cardiovascular Research at MedStar Heart and Vascular Institute in Washington, DC.

The study’s first patient was enrolled by Samin K. Sharma, MD, Director of Interventional Cardiology at Mount Sinai Heart in New York, New York.

“We are very excited to be part of this important trial, which addresses a true need to be able to treat patients and reduce the number of stents, offering the opportunity to uncage coronary arteries,” commented Dr. Sharma in Cordis’ press release.

Cordis stated that this study will complement the SELUTION DeNovo trial in Europe. More than 1,800 of the planned 3,326 patients have been enrolled in this randomized controlled study comparing the Selution SLR DEB with any limus drug-eluting stent (DES). The study is powered to demonstrate superiority of Selution SLR DEB over DES in coronary de novo artery disease.

Cordis is also studying the Selution SLR DEB for in-stent restenosis as part of the SELUTION4ISR IDE study. The study commenced enrollment in the United States in January 2023.

Dr. Waksman stated in the press release, “Use of DEBs in the treatment of coronary in-stent restenosis addresses the clear need for addressing restenosis without the use of additional stents. SELUTION4ISR along with the SLEUTION4DeNovo studies will provide important data on the efficacy and safety of sirolimus-eluting balloon with sustained drug release as a viable alternative to drug-eluting stent, leaving nothing behind post-PCI and eliminating in-stent restenosis and related complications.”

The Selution SLR DEB coronary, superficial femoral artery, and below-the-knee platforms are commercially available in Europe, the Middle East, a number of markets across Asia and Latin America, and most other countries where the CE Mark is recognized, advised the company.