iVascular is pleased to announce the outstanding results of the SOL Japan study, recently presented at the JET (Japan Endovascular Treatment)Conference. SOL Japan is a clinical trial aimed at evaluating the efficacy and safety of the Luminor 18 drug-coated balloon (DCB) in treating femoropopliteal (FP) arteries within the Japanese population. This pivotal study marks a significant milestone for Luminor DCB in Japan. The trial has been done in collaboration with Medico´s Hirata, a company with vast experience and knowledge of medical devices from Japan.
The SOL Japan study, under the expert guidance of Principal Investigator Dr. Yoshimitsu Soga from Kokura Memorial Hospital, is a prospective, multicenter, single-arm trial. A total of 122 patients were enrolled, with 57.4% of the participants being diabetic. The study focused on FP lesions, presenting a mean lesion length of 11 cm.
Key findings from the 12-month follow-up of the SOL Japan study include, primary Patency rate of 94.9%, freedom from target-lesion-revascularization rate of 99.2% and only 1 patient required revascularization within the first year.
These exceptional results underscore the high efficacy of Luminor DCB, with only one patient needing reintervention over the course of one year. This confirms that Luminor DCB’s TransferTech coating technology makes the difference, making it a top-class therapeutic option for FP lesions. TransferTech is last-generation nanotechnology that ensures minimal drug loss during navigation, fast and high drug transfer, and long retention time.
“Luminor DCB has showcased extraordinary performance in the SOL Japan study, significantly benefiting patients,” stated Dr. Yoshimitsu Soga. “The data reflects a major advancement in our ability to provide a safe and effective treatment with very low reintervention rate.”
