MedAlliance’s Selution SLR Drug-Eluting Balloon Receives IDE Approval for Coronary De Novo Study

January 10, 2023—MedAlliance announced that the company’s sirolimus-eluting balloon with sustained limus release (SLR), the Selution SLR, has received conditional approval from the FDA for an investigational device exemption (IDE) to initiate a pivotal clinical trial for the device in the treatment of coronary de novo lesions.

Enrollment of the SELUTION SLR coronary de novo study will begin in the United States within the next few months, advised the company.

Ron Waksman, MD, 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.

“Treatment of de novo coronary arteries with drug-eluting balloons is a breakthrough in revascularization of coronary artery disease,” commented Dr. Waksman in the company’s press releasee. “The SELUTION SLR coronary de novo study is the first of its kind in the United States and will provide important data on the efficacy and safety of a sirolimus-eluting balloon as a viable alternative to drug-eluting stents, leaving nothing behind post percutaneous coronary intervention and eliminating in-stent restenosis and related complications.”

The United States SELUTION SLR coronary de novo study will complement the SELUTION DeNovo trial in Europe, which has enrolled more than 800 patients of a planned 3,326 patients. This randomized controlled study is comparing the Selution SLR drug-eluting balloon versus any limus drug-eluting stent (DES). It is powered to demonstrate superiority of Selution SLR over DES in coronary de novo artery disease.

In October 2022, the company announced FDA approval of an IDE to initiate its coronary pivotal clinical trial of the Selution SLR to treat in-stent restenosis. The study has already begun enrollment in Europe.

Earlier in 2022, the FDA granted IDE approval for Selution SLR in the treatment of below-the-knee indications and IDE approval for occlusive disease of the superficial femoral artery.

In Europe, Selution SLR was awarded CE Mark approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020. The Selution SLR 014 percutaneous transluminal coronary angioplasty device is commercially available in Europe, Asia, the Middle East, and the Americas (outside the United States) and most other countries where the CE Mark is recognized, advised MedAlliance.