MedAlliance has announced enrollment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon Selution SLR for the treatment of patients with peripheral arterial disease (PAD). Selution SLR is a novel sirolimus-eluting balloon that provides a controlled, sustained release of the drug, similar to that of a drug-eluting stent (DES).
The objective of the study is to collect real-world safety, efficacy, health economics and patient reported quality-of-life data in over 700 patients with PAD treated with Selution SLR. It is a single-arm, all-comers study including all lower-limb indications and will cover at least 50 sites in Europe, Asia and South America. Patients will be followed-up at 30 days, six months, then every year out to five years.
The primary endpoint of the study is clinically driven target lesion revascularization (CD-TLR) at 12 months. Secondary endpoints include device success and procedure success and major adverse limb events (MALE).
“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 the study’s principal investigator Michael Lichtenberg, MD, a cardiologist based in Arnsberg, Germany.
In February 2020, MedAlliance received CE mark approval for Selution SLR in the treatment of PAD. This award was supported by results from the first-in-human study. 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 (MDR).
Selution SLR has also received Food and Drug Administration (FDA) Breakthrough Device designation for peripheral below-the-knee lesions as well as for the treatment of arteriovenous fistulae.
Selution SLR’s technology involves micro-reservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus.