The company won approval and reimbursement for its device last year from the Japanese Ministry of Health, Labor and Welfare for the treatment of peripheral artery disease in the upper leg.
Approval for Medtronic’s In.Pact Admiral system in Japan was based on data from its In.Pact SFA Japan study, which enrolled 100 patients and randomized them to receive either the DCB or standard percutaneous transluminal angioplasty. The DCB group experienced 93.9% primary patency at one year compared to 46.9% in the PTA group.
Data from the one-year mark also showed a CD-TLR rate of 2.9% for the DCB group, versus 18.8% in the PTA group, according to Medtronic.
“In Japan, there is a significant need for new technologies to safely and effectively treat PAD,” Tony Semedo, president of Medtronic’s Japan business, said in prepared remarks. “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.”
“We are incredibly proud to have paved the way for In.Pact Admiral and DCB technology in Japan,” Mark Pacyna, VP & GM of Medtronic’s peripheral business, added. “We worked closely with regulatory bodies to obtain both product and reimbursement approvals for In.Pact Admiral, and we have continued to demonstrate In.Pact Admiral’s superior safety and efficacy compared to PTA in a Japanese patient population. We look forward to bringing this proven technology to Japan and providing physicians with the tools they need to effectively treat PAD.”