Medtronic (NYSE:MDT) said today that its In.Pact Admiral drug-coated balloon won approval from the Japanese Ministry of Health, Labour and Welfare for the treatment of peripheral artery disease in the upper leg.

Before the medtech giant can begin commercialization of its drug-device combination product, it must gain reimbursement from the Japanese regulatory body, Medtronic said.

“The In.Pact Admiral DCB has demonstrated superior one-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,” Dr. Hiroyoshi Yokoi, from the Fukuoka Sannou Hospital, said in prepared remarks. “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.”

The product’s approval was supported by clinical data from the In.Pact SFA Japan Trial, which enrolled 100 patients and randiomized them to receive either the drug-coated balloon or plain balloon angioplasty.

The results were consistent with one-year findings from the company’s pivotal In.Pact SFA trial, demonstrating a low clinically-driven target lesion revascularization rate and high patency rate, Medtronic reported.

“Medtronic has long been committed to providing life-saving therapies to the more than 200 million patients suffering from PAD worldwide,” Mark Pacyna, VP & GM of Medtronic’s peripheral business in the cardiac & vascular group, added. “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.”

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