Ja­pan MHLW ap­proves Medtronic’s lat­est de­vice

BioSpectrum (Asia) - - Regulatory News -

Medtronic has ob­tained ap­proval from the Ja­panese Min­istry of Health, Labour and Wel­fare (MHLW) for its IN.PACT Ad­mi­ral drug-coated bal­loon (DCB) to treat pe­riph­eral artery dis­ease (PAD). The ap­proval cov­ers in­di­ca­tion of the DCB for PAD in up­per leg’s su­per­fi­cial femoral ar­ter­ies (SFA) in the thigh and popliteal ar­ter­ies be­hind the knee.

IN.PACT Ad­mi­ral is a clin­i­cally proven en­dovas­cu­lar ther­apy that fea­tures phys­i­cal di­lata­tion of the ves­sel lu­men by plain bal­loon an­gio­plasty (PTA) as the pri­mary mode of ac­tion.

The DCB’s pa­cli­taxel drug is in­tended to re­duce scar tis­sue for­ma­tion for pre­vent­ing artery nar­row­ing.

The lat­est ap­proval is based on re­sults from the IN.PACT SFA Ja­pan Trial per­formed in 100 pa­tients at 11 trial sites across the coun­try to com­pare the DCB with PTA.

At one year, pri­mary pa­tency was found to be 93.9 per cent with IN.PACT Ad­mi­ral com­pared with 46.9 per cent in PTA-treated pa­tients, while the clin­i­cally driven tar­get le­sion revas­cu­lar­i­sa­tion (CD-TLR) rate was 2.9 per cent for the DCB and 18.8 per cent in the PTA group.

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