MedAlliance SELUTION SFA Trial in Japan Reveals 12-Month Results

May 30, 2023—MedAlliance announced 12-month results from the prospective, multicenter, single-arm SELUTION SFA trial, which sought to assess the safety and efficacy of the company’s Selution SLR sirolimus-eluting balloon for endovascular therapy of de novo and nonstented restenotic lesions in the superficial femoral artery (SFA) and popliteal artery. The trial enrolled 134 patients at 13 sites in Japan.

The findings were presented for the first time at JET 2023, the Japan Endovascular Treatment conference held May 26-28 in Tokyo, Japan.

According to the company, the primary endpoint of 12-month primary patency of the target lesion was achieved in 87.9% of patients. Additionally, there was 97% freedom from target lesion revascularization, 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, noted MedAlliance.

“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,” commented Osamu Iida, MD, in the company’s press release. Dr. Iida is from Osaka Police Hospital Cardiovascular Center in Osaka, Japan.

On May 4, 2023, Medalliance announced the commencement of the SELUTION4SFA investigational device exemption (IDE) trial in the United States. In January 2018, the primary endpoint data from the first-in-human (FIH) study of the company’s Selution SLR device were presented by Principal Investigator Professor Thomas Zeller, MD, at the Leipzig Interventional Course in Leipzig, Germany.

In the press release, Jeffrey B. Jump, Chairman and CEO of MedAlliance, stated, “I loved Dr. Iida’s comment, ‘If limus is as effective as paclitaxel without the safety concerns, why would anyone not use limus?’ We are pleased to see that the Japanese 12-month data are completely aligned with the SELUTION FIH study done by Prof. Zeller 5 years ago. The United States IDE SFA study is now enrolling, which will hopefully confirm the same benefit in United States patients as we have seen in Europe and Japan.”

SELUTION SLR was awarded CE Mark approval for the treatment of coronary artery disease in May 2020 and is commercially available in Europe, Asia, the Middle East, the Americas (outside the United States), and most other countries where the CE Mark is recognized.