The first US patient has been enrolled in the SELUTION4SFA sirolimus drug-eluting balloon (DEB) study by Arthur Lee (Cardiac & Vascular Institute, Gainesville, USA).
This study evaluates SELUTION SLR in the treatment of occlusive disease of the superficial femoral artery (SFA) and proximal popliteal artery (PPA) and has been designed to support US Food and Drug Administration (FDA) approval. It follows investigational device exemption (IDE) approval in the US in August 2022. SELUTION SLR is the first and only limus release DEB to receive FDA IDE approval for SFA and PPA indications.
SELUTION4SFA is being conducted in over 30 centres in the US plus an additional 10 centres worldwide. The study will enrol 300 patients, with the aim of demonstrating the superiority of SELUTION SLR over balloon angioplasty (POBA). The primary efficacy endpoint is primary patency of the target lesion at 12 months and the primary safety endpoint is freedom from death at 30 days. Enrolment into the study will be complete by the end of 2023.
“We are excited to introduce the first Sirolimus DEB to US patients, and look forward to a rapid enrolment of this important study”, commented Jay Mathews (Manatee Memorial Hospital, Bradenton, USA), co-principal investigator. “We hope to learn how this technology can potentially benefit patients with complex peripheral arterial disease.”
“We are pleased to be enrolling our third IDE study in US patients, and look forward to the results of these three studies as well as future IDE studies to come”, added Jeffrey B Jump, chairman and CEO of MedAlliance.
SELUTION SLR was awarded CE mark approval for the treatment of coronary artery disease in May 2020. MedAlliance was the first drug-eluting balloon company to receive FDA Breakthrough Designation status. Currently three IDE clinical studies are evaluating SELUTION SLR in the US: in CLTI patients with BTK disease; SFA/PPA; and coronary ISR. In addition, MedAlliance received IDE approval for de novo coronary artery lesions in January 2023. This complements the substantial experience that the company has gained with the SELUTION DeNovo and SUCCESS trials in Europe.
MedAlliance’s unique DEB technology involves MicroReservoirs which contain a combination of biodegradable polymer intermixed with the anti-restenotic drug sirolimus, applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. MedAlliance’s proprietary CAT (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.
SELUTION SLR is commercially available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries where the CE mark is recognised. Over 10,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials.