iVascular today announced that the recruitment of the prospective, multicenter, consecutive, post-market LUMIFOLLOW trial has begun. This trial was created with the aim of evaluating the performance of Luminor DCB in femoropopliteal lesions of real-world patients.
Prof. Eric Ducasse (CHU Bordeaux, France), is LUMIFOLLOW trial principal investigator: “Over the last 2 years, several publications have confirmed that Paclitaxel DCBs are safe. Luminor DCB, with its unique technology, has already proven to be highly effective in selective indications. We expect LUMIFOLLOW real-world data to reinforce both evidence, and confirm that Paclitaxel DCBs, alone or combined with stents, must be the routine gold standard in femoropopliteal indications”.
The LUMIFOLLOW trial will enroll 500 patients of 20 centers in France, with 5 years follow up. Overall medical safety and primary patency will be assessed as primary endpoints.
Dr. Nicolas Louis has enrolled the 1st LUMIFOLLOW patient at Les Franciscaines Private Hospital in Nimes, France: “I have been using Luminor DCB in my daily practice since it got reimbursed in France. I do appreciate its clinical performance as well as ease of use”.
“ The LUMIFOLLOW trial is the next step of the iVascular clinical program dedicated to Luminor DCB. The EffPac randomized controlled trial demonstrates that Luminor DCB efficacy is maintained over years and proves Transfertech coating long-term safety. The TINTIN trial proves Luminor DCB efficacy even in the most complex lesions. Our objective is now to demonstrate that Luminor DCBs outcomes are reproducible in standard practice with all-comers patients”, stated Lluís Duocastella, CEO of iVascular SLU.
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.