iVascular's luminor DCB Gains Reimbursement in France

October 4, 2019—iVascular S.L.U. announced that its luminor 18 and 35 drug-coated balloons (DCBs) are now listed on France's LPPR, the country’s medical device reimbursement list, for the treatment of de novo lesions in the femoropopliteal arteries.

According to the company, the luminor DCB is a paclitaxel-coated balloon designed for dilatation of stenoses located in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries. The device is also able to treat obstructive lesions of arteriovenous fistulas, whether original or artificial.

The luminor DCB uses proprietary coating nanotechnology, TransferTech, to spread paclitaxel in a microcrystalline structure on the balloon, together with the excipient, using an ultrasound spray pulse. The balloon surface is covered with multiple, independent nanodrops layers, providing a flexible coating that adapts to the balloon movement and ensures that paclitaxel is released in the target lesion without particle loss in the blood flow, advised iVascular.

Professor Eric Ducasse, MD, commented in the company’s announcement, “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.” Prof. Ducasse is Head of the Vascular and General Surgery Department at CHU Bordeaux in Bordeaux, France.

The company highlighted the latest 2-year data reported from the EffPac trial that showed outstanding primary patency (90.2%) and freedom from target lesion revascularization (97.2%) in the superficial femoral and popliteal arteries for TASC A and B lesions. EffPac has also shown no increased risk of death at 2 years (one death in the DCB group vs two deaths in the plain old balloon angioplasty group; relative risk, 0.48), noted iVascular.