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.
Medtronic Cardiac and Vascular Group Peripheral business vice-president and general manager Mark Pacyna said: "Medtronic has long been committed to providing life-saving therapies to the more than 200 million patients suffering from PAD worldwide.
"IN.PACT Admiral was launched more than seven years ago in Europe. Now, with more than 200,000 patients treated, we are excited to bring IN.PACT Admiral DCB to patients in Japan."
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% with IN.PACT Admiral compared with 46.9% in PTA-treated patients, while the clinically driven target lesion revascularisation (CD-TLR) rate was 2.9% for the DCB and 18.8% in the PTA group.
The low CD-TLR and high patency rates were observed to be consistent with previous trial data.
Image: Medtronic operational headquarters. Photo: courtesy of Medtronic plc.