Medtronic's In.Pact Admiral DCB Approved in Japan

September 8, 2017—Medtronic announced that its In.Pact Admiral drug-coated balloon (DCB) received approval from the Japanese Ministry of Health, Labor, and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the superficial femoral arteries (SFAs) and popliteal arteries. The company noted that before beginning commercialization, it must partner with the Japanese MHLW to gain reimbursement to ensure broader access to this therapy.

The paclitaxel-coated In.Pact Admiral device has been approved in Japan to treat de novo and nonstented restenotic lesions with lengths ≤ 200 mm in the SFA and popliteal arteries with reference vessel diameters of ≥ 4 mm and ≤ 7 mm.

According to the company, the MHLW granted approval for the In.Pact Admiral DCB based on clinical data from the IN.PACT SFA Japan trial led by Osamu Iida, MD, and Hiroyoshi Yokoi, MD.

The study enrolled 100 patients across 11 sites in Japan and randomized treatment to either DCB (n = 68) or percutaneous transluminal angioplasty (PTA; n = 32). The results 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 high patency rate.

Medtronic noted that the IN.PACT SFA Japan trial demonstrated 93.9% primary patency in the DCB group versus 46.9% in the PTA group at 1 year based on Kaplan-Meier estimate (P < .001). Additionally, 1-year results demonstrated a CD-TLR rate of 2.9% for the DCB group versus 18.8% in the PTA group (P = .012). Major adverse events were also lower for the DCB group at 1 year at 4.4% versus 18.8% in the PTA group (P = .028), with no major target limb amputations, reported the company.

In Medtronic's press release, Dr. Yokoi commented, "The In.Pact Admiral DCB has demonstrated superior 1-year clinical outcomes in Japan and across Medtronic IN.PACT SFA clinical trials, providing patients with an improved restoration of blood flow and reduced need for additional revascularization compared to plain balloon angioplasty, a current standard of care. In the IN.PACT SFA Japan trial, the DCB demonstrated superior patency and lower reintervention rates. I look forward to treating PAD patients in Japan with this durable, consistent, and safe DCB technology."