Medtronic's In.Pact Admiral DCB Launched in Japan

August 15, 2018—Medtronic announced full commercial launch of its In.Pact Admiral drug-coated balloon (DCB) in Japan, which comes after completion of enrollment in the 300-patient postmarket clinical trial of the device.

In 2017, the paclitaxel-coated In.Pact Admiral received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of peripheral artery disease in the superficial femoral artery and popliteal artery. The device has been approved in Japan to treat de novo and nonstented restenotic lesions with lengths ≤ 200 mm in superficial femoral and popliteal arteries with reference vessel diameters ≥ 4 mm and ≤ 7 mm. The MHLW also granted reimbursement approval for In.Pact Admiral.

According to Medtronic, approval for In.Pact Admiral in Japan was supported by data from MDT-2113, the IN.PACT SFA Japan trial that enrolled 100 patients at 11 sites. The trial randomized treatment to either DCB use (n = 68) or standard percutaneous transluminal angioplasty (PTA) (n = 32). The results from the IN.PACT SFA Japan trial were consistent with 1-year findings from the pivotal IN.PACT SFA trial, showing a low clinically driven target lesion revascularization (CD-TLR) rate and a high patency rate.

The company reported that IN.PACT SFA Japan demonstrated 93.9% primary patency in the DCB group compared to 46.9% in the PTA group at 1 year based on Kaplan-Meier estimate (P < .001). Additionally, 1-year results showed a CD-TLR rate of 2.9% for the DCB group compared to 18.8% in the PTA group (P = .012). In IN.PACT SFA Japan, major adverse events were also lower for the DCB group at 1 year (4.4% vs 18.8% in the PTA group; P = .028), with no major target limb amputations or all-cause death in both treatment groups.

Additionally, 2-year data from IN.PACT SFA Japan were presented in January at LINC 2018, the Leipzig Interventional Course in Leipzig, Germany. Results were also consistent with 2-year findings from the IN.PACT SFA trial.