iVascular Luminor 18 RX DCB Launched in Japan

May 6, 2025—iVascular and Medico’s Hirata recently announced that the Vascular Luminor drug-coated balloon (DCB) has received regulatory approval from Japan’s Ministry of Health, Labour, and Welfare.

iVascular is based in Barcelona, Spain, and Medico’s Hirata is a Japan-based medical company specializing in the distribution of advanced health care solutions.

iVascular stated that it has developed a Luminor device specifically for Japan—the rapid-exchange Luminor 18 RX DCB. The company advised that this tailored approach is intended to ensure a solution specifically optimized for the clinical practices of Japanese health care providers.

Yoshimitsu Soga, MD, a vascular specialist in Japan, is coordinating investigator of the Luminor SOL-Japan trial.

“We have been eagerly awaiting the availability of this product in Japan,” commented Dr. Soga in iVascular’s press release. “The excellent navigation capabilities of the Oceanus platform and the strong clinical results of Luminor in the SOL-Japan trial (99.2% freedom from target lesion revascularization at 1 year) make it a highly promising solution for our patients.”

In July 2024, iVascular announced that the first 12-month results of the SOL-Japan trial were presented at JET, the Japan Endovascular Treatment conference in Fukuoka, Japan.