May 30, 2023 — Twelve-month results from the SELUTION SFA trial have been presented for the first time at the Japan Endovascular Treatment (JET) Conference in Tokyo. The objective of this study was to assess the safety and efficacy of SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon, for endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and popliteal artery (PA).
The prospective, multicenter single arm trial has involved 134 patients treated across 13 sites in Japan. The primary endpoint of 12-month primary patency of the target lesion was achieved in 87.9% of patients. There was 97% freedom from 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 DCB!”, said Dr. Osamu Iida, Osaka Police Hospital Cardiovascular Center, Osaka, Japan.
“I loved Dr Iida’s comment, ‘if limus is as effective as paclitaxel without the safety concerns, why would anyone not use limus?”, commented Jeffrey B. Jump, Chairman and CEO of MedAlliance. “We are pleased to see that the Japanese 12 month data is completely aligned with the FIM done by Professor Zeller five years ago. The US IDE SFA study is now enrolling, which will hopefully confirm the same benefit in US 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. MedAlliance was the first drug-eluting balloon (DEB) 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 recognized. Over 10,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials. Please contact us if your centre is interested in participating in this study.
For more information: www.medalliance.com