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The first peripheral drug-coated balloon is approved for add-on reimbursement in France
Ministerial decree to enlist Medtronic's IN.PACT Admiral for the LPPR title V for add-on reimbursement was published on 6th of May 2017 in the Official Journal of French Republic. This is not only the first peripheral DCB on the list, but one of the first invasive non-implantable devices to get add-on reimbursement in France.
National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) issued a positive opinion and recommended technology for inclusion into reimbursement scheme in May 2016. CNEDiMTS has recommended it for use within the following indications:
- in the treatment of arterial occlusive disease of the lower limbs, symptomatic in the critical ischemic stage or intermittent claudication due to de novo lesion (stenosis of length ≤ 18 cm and ≥ 70%) or occlusion (≤ 10 cm) of the femoro-popliteal artery above the knee with a reference diameter of 4 to 7 mm.
Level of added clinical value was found moderate (level III) in comparison with plain balloon.
It took one year since positive decision by CNEDiMTS until start of add-on reimbursement. Reassessment of price and reimbursement status will be performed in 5 years, in 2022.
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