Cordis Selution SLR’s SUCCESS PTA Study Completes Enrollment

October 24, 2023—Cordis announced completion of patient enrollment in the postmarket SUCCESS PTA study of the company’s Selution SLR drug-eluting balloon (DEB), which is designed to provide a controlled, sustained release of sirolimus for the treatment of patients with peripheral artery disease.

According to the company, the objective of the SUCCESS PTA study is to collect real-world safety, efficacy, health economics, and patient-reported quality-of-life data in more than 700 patients with PAD treated with the Selution SLR DEB.

The single-arm, all-comers study includes all lower limb indications (superficial femoral artery [SFA]; below the knee [BTK]; foot). At least 50 sites in Europe, Asia, and South America will enroll patients, who will be followed-up at 30 days, 6 months, and then every year out to 5 years.

The primary endpoint of the study is clinically driven target lesion revascularization at 12 months. Secondary endpoints include device success and procedure success; major adverse limb events; and target limb revascularization. Data from the SUCCESS PTA study will be part of the clinical evidence supporting CE Mark renewal under the European Medical Device Regulation as the European Union transitions from the Medical Devices Directive regulatory framework. Selution SLR DEB received CE Mark approval for the treatment of peripheral artery disease in February 2020. In the United States, the device has received investigational device exemption approval from the FDA for BTK and SFA indications in May and August 2022, respectively.

Michael Lichtenberg, MD, serves as the study’s Principal Investigator. Dr. Lichtenberg is Director of the Angiology and Vascular Center in Arnsberg, Germany.

“Given the impressive performance of this novel device in earlier studies, we are very excited to see how Selution SLR DEB will perform in a larger group of patients in a real-world setting,” commented Dr. Lichtenberg in the company’s press release.

MedAlliance, the developer of Selution SLR, was acquired by Cordis in October 2023.