MedAlliance has announced enrolment 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 artery 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 (SFA; BTK; Foot) 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; Major Adverse Limb Events (MALE); and Target Limb Revascularization (TLR).
“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, Arnsberg, Germany.
“SUCCESS PTA is part of the SUCCESS post-market study family, designed to show patient benefits in real-world use of our technology,” added Chairman and CEO Jeffrey B. Jump. “This is the largest study we have ever undertaken with SELUTION SLR, involving the most diverse group of patients. We are confident that the results will confirm the safety, efficacy, and cost-effectiveness of our sirolimus-eluting balloon.”
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 US Food and Drug Administration (FDA) Breakthrough Device Designation Status for peripheral below-the-knee lesions as well as for the treatment of AV-Fistula.
SELUTION SLR’s technology involves unique MicroReservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustained release of the drug. Extended-release of sirolimus from stents has been proven highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via an angioplasty balloon.