Luminor 18 and Luminor 35 drug-coated balloons (DCB; iVascular) are now listed on the French LPPR list for de novo lesions of the femoropopliteal arteries.
Luminor is a paclitaxel-coated balloon specifically designed for dilatation of stenosis located in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas, whether original or artificial.
Eric Ducasse (CHU Bordeaux, Vascular Surgery Unit, France) has been one of the first Luminor users in France. He comments: “Luminor is the first paclitaxel DCB reimbursed in France since the Katsanos et al publication. It underlines that French authorities do trust its last generation coating technology, which is unique and has demonstrated efficacy, and, above all, safety. I am confident that French use and data analysis will confirm it shortly.”
The latest EFFPAC trial two-year outcomes with Luminor have shown positive results in terms of primary patency (90.2%) and freedom from target lesion revascularisation (97.2%) in the superficial femoral artery and popliteal artery for TASC A and B lesions. The trial also demonstrated no increased risk of death detected at two-years (one death in the DCB group versus two deaths in the percutaneous transluminal angioplasty group), evidencing a relative risk of 0.48.
The Luminor DCB has a proprietary nanotechnology coating, TransferTech. This uses paclitaxel in a microcrystalline molecular structure that is spread on the balloon, together with the excipient, by ultrasound spray pulse. The balloon surface is covered with multiple and independent nanodrop layers, providing a flexible coating that adapts to the balloon movement and ensures paclitaxel is released in the target lesion without particle loss in the blood flow.