iVascular’s Luminor 18 DCB Studied in Japan to Treat Femoropopliteal Disease

July 22, 2024—iVascular announced that the first results of the SOL Japan clinical trial were presented at JET, the Japan Endovascular Treatment conference held June 14-16 in Fukuoka, Japan.

According to the company, SOL Japan is a pivotal trial aimed at evaluating the efficacy and safety of iVascular’s Luminor 18 drug-coated balloon (DCB) in treating femoropopliteal arteries in the Japanese population. In April 2021, the company announced the commencement of the trial.

iVascular stated that the prospective, multicenter, single-arm trial enrolled a total of 122 patients, with 57.4% of the patients being diabetic. It focused on femoropopliteal lesions with a mean lesion length of 11 cm.

As summarized in the press release, key findings from the study’s 12-month follow-up include a primary patency rate of 94.9% and a freedom from target lesion revascularization rate of 99.2%. Additionally, only one patient required revascularization within the first year.

The company stated that the results demonstrated the efficacy of the Luminor DCB with its TransferTech coating technology as a therapeutic option for femoropopliteal lesions. TransferTech is a latest-generation nanotechnology intended to ensure minimal drug loss during navigation; fast and high drug transfer; and long retention time.

The study’s principal investigator is Yoshimitsu Soga, MD, from Kokura Memorial Hospital in Fukuoka.

“Luminor DCB has showcased extraordinary performance in the SOL Japan study, significantly benefiting patients,” commented Dr. Soga in the company’s press release. “The data reflects a major advancement in our ability to provide a safe and effective treatment with very low reintervention rate.”

The SOL Japan trial is being conducted in collaboration with Medico’s Hirata, a company with experience and knowledge of medical devices from Japan, noted iVascular.