iVascular has announced that its Luminor drug-coated balloon (DCB) is now available in Japan.
“This approval from the MHLW [Ministry of Health, Labour and Welfare of Japan] is evidence of the quality, safety, and efficacy of Luminor DCB,” said Lluis Duocastella, chief executive officer 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.”
iVascular notes that Medico’s Hirata is a renowned Japanese medical company specialised 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 excellent clinical evidence,” the company states in a press release.
iVascular shares that it has developed a Luminor specifically for Japan—Luminor 18 RX, which the company claims is the most capable peripheral rapid exchange DCB currently available in the Japanese market.
Yoshimitsu Soga (Kokura Memorial Hospital, Fukuoka, Japan), coorinatimg investigator of Luminor’s trial in Japan (SOL-Japan trial), states in a press release: “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 [freedom from target lesion revascularisation] at one year), make it a highly promising solution for our patients.”
