Twelve-month results from the SELUTION SFA trial have been presented for the first time at the Japan Endovascular Treatment (JET) Conference (26–28 May, Tokyo, Japan). The objective of this study was to assess the safety and efficacy of the Selution SLR sirolimus-eluting balloon (MedAlliance) for the endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and popliteal artery (PA).
The prospective, multicentre, single-arm trial has involved 134 patients treated across 13 sites in Japan. A press release reports that the primary endpoint of 12-month primary patency of the target lesion was achieved in 87.9% of patients; there was 97% freedom from target lesion revascularisation (TLR); no major amputations or deaths; and a 0.7% rate of thrombosis. These results were achieved despite the presence of challenging patients enrolled in the study.
“These data demonstrate that limus can be as effective as paclitaxel without the associated safety concerns and welcomes a new era for [drug-coated balloons]”, said Osamu Iida (Osaka Police Hospital Cardiovascular Center, Osaka, Japan).
“We are pleased to see that the Japanese 12-month data [are] completely aligned with the [first-in-man] done by Professor Zeller five years ago,” commented Jeffrey B Jump, chairman and CEO of MedAlliance. The US [investigational device exemption] SFA study is now enrolling, which will hopefully confirm the same benefit in US patients as we have seen in Europe and Japan.”
The company advises that 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.