B. Braun has announced the recent French reimbursement approval for its peripheral drug-coated balloon (DCB) SeQuent Please OTW effective as of July 2018.
As published in the Official Journal of the French Republic, B. Braun’s over-the-wire DCB is now reimbursed under Title V in the list of reimbursable products and services (LPPR).
According to this announcement, hospitals in France receive an add-on reimbursement with SeQuent Please OTW in its 035 version to treat peripheral arterial disease in femoro-popliteal lesions.
SeQuent Please OTW is a peripheral paclitaxel-coated balloon with a nominal dose of 3 µg/mm2 that is integrated into a matrix with resveratrol. This excipient is a naturally occurring, plant based substance with positive anti-inflammatory, antioxidant & anti-hypertensive characteristics.
The basis for the positive opinion for B. Braun’s DCB issued by the French National Commission for the Evaluation of Medical Devices and Health Technologies is the solid clinical evidence of the CONSEQUENT randomised controlled trial. After 24 months the results in 153 patients (1:1 DCB vs. plain balloon angioplasty) with challenging femoro-popliteal lesions (23.5% with TASC C/D lesions, mean lesion length of 14.5cm) demonstrated a significantly higher primary patency rate in the DCB group (72.3 vs. 48.4%; p=0.006) with no further TLR after 14 months.
Furthermore, SeQuent Please OTW is the only DCB available in France with guidewire compatibilities of 0.014”, 0.018” and 0.035” to treat above-the-knee and below-the-knee lesions.