B. Braun's SeQuent Please OTW DCB Gains Reimbursement Approval in France
August 1, 2018—B. Braun announced that the SeQuent Please OTW platform—the company's over-the-wire peripheral drug-coated balloon (DCB)—gained reimbursement approval in France, effective July 2018. The device includes paclitaxel in a nominal dose of 3 µg/mm2 that is integrated into a matrix with Resveratrol. In France, the device is available with guidewire compatibilities of 0.014, 0.018, and 0.035 inches to treat above-the-knee and below-the-knee lesions.
As published in the Official Journal of the French Republic, the French National Commission for the Evaluation of Medical Devices and Health Technologies approved reimbursement of the SeQuent Please OTW under Title V in the list of reimbursable products and services. Hospitals in France receive an add-on reimbursement with SeQuent Please OTW in its 035 version to treat peripheral arterial disease in femoropopliteal lesions.
According to B. Braun, the basis for the commission's positive opinion for the SeQuent Please OTW is the clinical evidence of the CONSEQUENT randomized controlled trial. After 24 months, the results in 153 patients (1:1 DCB vs plain old balloon angioplasty) with challenging femoropopliteal lesions (23.5% with TASC C/D lesions, mean lesion length of 13.2 cm) demonstrated a significantly higher primary patency rate in the DCB group (72.3% vs 48.4%; P = .006) with no further TLR after 14 months.