The Selution sustained limus release (SLR) Sustane drug-eluting balloon (DEB; MedAlliance/Cordis) has achieved patency results (90.3%) in line with best-in-class paclitaxel devices and the highest reported Kaplan-Meier (KM) rate in a superficial femoral artery (SFA) investigational device exemption (IDE) trial to date. This is according to Jay Mathews (Manatee Memorial Hospital/Bradenton Cardiology Center, Bradenton, USA), who has just shared late-breaking 12-month results from the SELUTION4SFA randomised controlled trial (RCT) at Vascular InterVentional Advances (VIVA; 4–7 October, Las Vegas, USA).
SELUTION4SFA compared the Selution SLR Sustane DEB to balloon angioplasty for the treatment of femoropopliteal artery lesions. The trial enrolled 300 patients between April 2023 and June 2025. Patients were randomised 2:1, with 205 assigned to the Selution SLR DEB group and 95 to the plain balloon angioplasty group. At 12 months, 176 (85.9%) patients in the Selution group had completed enrolment, compared to 82 (86.3%) in the angioplasty group.
Mathews reported that the SELUTION4SFA trial successfully met the statistical threshold for superiority to plain balloon angioplasty (p=0.019) and that the Selution device demonstrates clinical efficacy for a sirolimus-eluting balloon equating that of approved paclitaxel devices with a proven safety profile for SFA disease.
The presenter also noted the consistency of results across SELUTION trials, citing SFA Japan and the SUCCESS registry, as well as across vessel beds.
