Luminor (iVascular) drug-coated balloon (DCB) has confirmed its excellent safety and efficacy in femoropopliteal lesions with new study LUMIFOLLOW, a recent press release states.
iVascular presented at Paris Vascular Insights (PVI) 2023 (8–10 November, Paris, France), delivering one year outcomes of the prospective, multicentre, consecutive, post-market study LUMIFOLLOW. This trial aimed to evaluate the performance of Luminor DCB in femoropopliteal lesions of 534 real-world patients, up to five years follow-up.
The trial included 77% patients with Rutherford stage higher than three from different centres from France. The average lesion length was 13cm and all type of TASC were included. In this cohort, 24% of the lesions were restenosis’, while the 76% were de novo. The bailout stenting rate was 43%, representing the percentage of TASC C and D lesions.
At one year follow-up an impressive 95.4% of freedom from target lesion revascularisation (fTLR) has been achieved, and a fTVR of 94.2%. At one year, patient symptomatology had decreased and 68% of the patients are asymptomatic (Rutherford stage 0). No safety concerns have been detected, the press release outlines.
Eric Ducasse (Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux, France), LUMIFOLLOW trial principal investigator, who was in charge of presenting the outcomes for the first time, stated: “LUMIFOLLOW confirms what we already knew about Luminor with a large population number: it’s an effective DCB for the treatment of femoropopliteal arteries. iVascular’s proprietary nanotechnology makes the difference vs other DCBs.”
