Barcelona, Spain – iVascular and Medico’s Hirata announce that Luminor Drug Coated Balloon (DCB) has received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW).
iVascular, a leading medical device technology company based in Barcelona, has important expertise in creating cardiovascular solutions as DCBs. This milestone marks a significant step in iVascular’s global expansion and commitment worldwide.
“This approval from the MHLW is the evidence to the quality, safety, and efficacy of Luminor DCB,” said Lluis Duocastella, CEO at iVascular. “We are thrilled to bring this innovation to the Japanese market together with Medico’s Hirata, as we continue our mission to improve vascular health worldwide.”
Medico’s Hirata is a renowned Japanese medical company specialized in the distribution of advanced healthcare solutions. This partnership will ensure that Japanese healthcare professionals and patients have access to a safe and effective DCB, with recognized excellent clinical evidence.
As a company committed to adapting its products to meet the specific needs of different markets, iVascular has developed a Luminor specifically for Japan: Luminor 18 RX. Luminor 18 RX is the most capableperipheral rapid exchange DCB currently available in the Japanese market. This tailored approach ensures that Japanese healthcare providers benefit from a solution specifically optimized for their clinical practices.
Dr. Yoshimitsu Soga, a leading vascular specialist in Japan, and coorinatimg investigator of Luminor’s trial in Japan (SOL-Japan trial) claimed that: “We have been eagerly awaiting the availability of this product in Japan. The excellent navigation capabilities of the Oceanus platform and the strong clinical results of Luminor in the SOL- Japan trial (99.2% fTLR at 1-year), make it a highly promising solution for our patients.”
For more information about iVascular and Medico’s Hirata, please visit ivascular.global and medicos-hirata.
