iVascular’s Luminor DCB Evaluated in Postmarket LUMIFOLLOW Trial in Europe

February 11, 2021—iVascular announced commencement of enrollment in the prospective, multicenter, consecutive, postmarket LUMIFOLLOW trial, which is evaluating the performance of company’s Luminor drug-coated balloon (DCB) in femoropopliteal lesions of real-world patients.

According to the company, the LUMIFOLLOW trial will enroll 500 patients at 20 centers in France. Follow-up will be 5 years. Overall medical safety and primary patency will be assessed as primary endpoints.

The trial’s Principal Investigator is Professor Eric Ducasse, MD, of CHU Bordeaux in Bordeaux, France. Nicolas Louis, MD, enrolled the first patient in the trial at Les Franciscaines Private Hospital in Nimes, France.

According to the company, Luminor is a paclitaxel-coated balloon with platforms for different guidewire compatibility of 0.014, 0.018, and 0.035 inches. It is 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 as well as below-the-knee arteries, noted iVascular.

In the company’s announcement, Prof. Ducasse commented, “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.” Dr. Louis added, “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.”