iVascular has announced that “outstanding” results from the SOL Japan study were recently presented at the Japan Endovascular Treatment (JET) conference (14–16 June, Fukuoka, Japan).
SOL Japan is a clinical trial aimed at evaluating the efficacy and safety of the Luminor 18 drug-coated balloon (DCB) in treating femoropopliteal arteries within the Japanese population.
A press release notes that this pivotal study marks a significant milestone for the Luminor DCB in Japan. The trial has been conducted in collaboration with Medico’s Hirata, a company from Japan that iVascular states has vast experience and knowledge of medical devices.
The SOL Japan study, under the guidance of principal investigator Yoshimitsu Soga from Kokura Memorial Hospital (Kitakyushu, Japan), is a prospective, multicentre, single-arm trial. A total of 122 patients were enrolled, with 57.4% of the participants being diabetic. The study focused on femoropopliteal lesions, presenting a mean lesion length of 11cm.
Key findings from the 12-month follow-up of the SOL Japan study include a primary patency rate of 94.9% and a freedom from target lesion revascularisation rate of 99.2%. In addition, only one patient required revascularisation within the first year.
According to iVascular, these 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, the company adds, making it a top-class therapeutic option for femoropopliteal lesions. iVascular advises that 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,” Soga stated in a press release. “The data reflect a major advancement in our ability to provide a safe and effective treatment with very low reintervention rate.”
