SUCCESS PTA Study of MedAlliance’s Selution SLR Begins Enrollment

February 8, 2021—MedAlliance announced the enrollment of the first patient in the SUCCESS PTA postmarket study of the company’s Selution SLR drug-eluting balloon for the percutaneous transluminal angioplasty (PTA) treatment of patients with peripheral artery disease (PAD). Selution SLR is a sirolimus-eluting balloon.

According to the company, the study’s objective 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 device. The single-arm, all-comers study includes all lower limb indications (superficial femoral artery, below the knee, and foot) and will be conducted in at least 50 sites in Europe, Asia, and South America. Follow-up will be conducted at 30 days, 6 months, and 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 and procedure success, major adverse limb events, and target limb revascularization.

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

The company advised that data from the SUCCESS PTA study will be part of the clinical evidence supporting CE Mark renewal in 2023-2024 under the new European Medical Device Directive.

In February 2020, MedAlliance received European CE Mark approval for Selution SLR in the treatment of PAD, which was supported by results from the first-in-human study. Selution SLR has also received FDA Breakthrough Device designation for peripheral below-the-knee lesions as well as for the treatment of arteriovenous fistula.