Medtronic's In.Pact Admiral DCB Approved for Reimbursement in France and Belgium

June 9, 2017—Medtronic announced the recent reimbursement approvals in France and Belgium for its In.Pact Admiral peripheral drug-coated balloon (DCB) for the treatment of peripheral artery disease (PAD).

In France, a ministerial decree was published in the Official Journal of the French Republic to enlist Medtronic's In.Pact Admiral peripheral DCB for the Liste des Produits et Prestations Remboursables (LPPR) title V for add-on reimbursement in the treatment of PAD in the upper leg. France's National Commission for the Evaluation of Medical Devices and Health Technologies issued a positive opinion and recommended the In.Pact Admiral for reimbursement.

Effective May 19, the In.Pact Admiral is the first peripheral DCB approved for reimbursement in France for the treatment of PAD. Additionally, In.Pact Admiral is one of the first invasive nonimplantable devices to obtain this new add-on reimbursement in France under the newly created LPPR title V legislation.

In Belgium, Medtronic received reimbursement approval for the In.Pact Admiral DCB effective April 1, 2017. The company noted that In.Pact Admiral is the first DCB to be approved for reimbursement in Belgium and that the reimbursement approval is based on a body of robust scientific evidence demonstrating significantly superior clinical outcomes and cost-effectiveness versus alternatives.

The Belgian Ministry of Health specifies that only DCBs that have demonstrated a statistically significant reduction in the rate of revascularization will be eligible for reimbursement in Belgium, advised Medtronic.