Medtronic Announces Commercial Launch of the IN.PACT Admiral Drug-Coated Balloon in Japan

Medtronic (NYSE:MDT) today announced full commercial launch of the IN.PACT Admiral Drug-Coated Balloon (DCB) in Japan. The news follows the completion of a post-market clinical trial, which enrolled 300 subjects.

As quoted in the press release:

IN.PACT Admiral received approval last year from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of peripheral artery disease (PAD) in the upper leg – specifically, in the thigh (superficial femoral arteries (SFA)) and behind the knee (popliteal arteries). The MHLW also granted reimbursement approval for the IN.PACT Admiral in December of 2017.

“In Japan, there is a significant need for new technologies to safely and effectively treat PAD,” said Tony Semedo, president, Medtronic Japan. “Earlier this year, we presented both one- and two-year results from the IN.PACT SFA Japan study, representing consistency in clinical data shared on IN.PACT Admiral to-date. Now with the completion of our post-market study, we will become the first company to bring DCB technology to Japanese physicians and their patients.”

Approval for IN.PACT Admiral in Japan was based on data from MDT-2113 (IN.PACT SFA Japan), which enrolled 100 patients across 11 sites and randomized treatment to either DCB (n=68) or standard percutaneous transluminal angioplasty (PTA) (n=32). The results were consistent with one-year findings from the pivotal IN.PACT SFA Trial, showing a low clinically-driven target lesion revascularization (CD-TLR) rate and high patency rate.

Click here to read the full press release.