Barcelona, 15th of April 2021. We are pleased to announce the commencement of recruitment of Luminor’s first study in Japan (SOL-JAPAN Trial) together with Medicos Hirata, a Japanese company. The trial is the first step for obtaining registration for Luminor DCB in the country, meaning it is key to the introduction of Luminor in the Japanese market.
iVascular is proud to be present in Japan through its partnership agreement with Medico´s Hirata, a company with vast experience and knowledge of medical devices and peripheral pathology. This represents a big step for the global growth of iVascular, with Japan representing around 1,7% of the total global population and benefits Medico’s Hirata with a wide range of high-quality products.
Luminor has previously demonstrate its high efficacy with a fTLR of 90.1% and excellent safety outcomes with zero risk of death at 3.5 years in femoropopliteal arteries. Now that the safety of paclitaxel devices has been proven, its and opportunity to evaluate the efficacy of Luminor in the Japanese population.
“The Long-term safety of paclitaxel containing devices in Japan” report and several other publications have confirmed that paclitaxel DCBs are safe.” Stated Dr Yoshimitsu Soga
The trial with Luminor DCB is a single-arm, prospective, multicenter, non-randomized open trial, to evaluate the safety and effectiveness of Luminor DCB when treating superficial femoral artery and proximal popliteal artery lesions. Its primary endpoint is the primary patency of the target lesion at 12 months after procedure and the secondary endpoints are device success, procedural success, and clinical success, among others. The study will enroll 120 participants of centers in Japan followed through 5 years with assessments at 30 days, 6 months, and each year until 5 years are reached.
The first case of this Luminor clinical trial was successfully conducted at Kokura Memorial Hospital in February 2021 by Dr. Yoshimitsu Soga, investigator coordinator of the trial who stated that:
“Staring a trial with Luminor DCB in Japan it’s an opportunity to corroborate the efficacy of Luminor and the safety of paclitaxel at long-term follow-up.”
The results of this trial will be key to initiate the commercialization of Luminor in Japan. Luminor has already demonstrated its high efficacy and safety in 7 other clinical trials obtaining astonishing results in different indications and long-term follow-up.
Luminor is a paclitaxel-coated balloon with platforms for different guidewire compatibility: 0.014”, 0.018” and 0.035”. It’s specifically designed to treat stenosis located in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, either original or artificial.
Luminor has demonstrated to be highly effective and safe in femoropopliteal and even in BTK arteries. The great outcomes obtained in various clinical trials prove that not all DCBs are the same.
The unique iVascular proprietary coating nanotechnology, TransferTech, differentiates Luminor DCB from others. The balloon surface is covered with multiple and independent nano drops layers, providing a flexible coating that adapts to the balloon movement and ensures the release of paclitaxel in the target lesion, without particle loss in the blood flow.