Japan MHLW approves Medtronic’s latest device
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.