Dublin-based Medtronic has announced the commercial launch of the IN.PACT Admiral Drug-Coated Balloon (DCB) in Japan.
This news follows the completion of a post-market clinical trial, which was conducted on 300 subjects.
Last year, the Japanese Ministry of Health, Labor and Welfare (MHLW) granted approval for IN.PACT Admiral 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 IN.PACT Admiral has also received reimbursement approval last December from the MHLW.
Medtronic Japan president Tony Semedo said: “In Japan, there is a significant need for new technologies to safely and effectively treat PAD.
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“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.”
MHLW approved the IN.PACT Admiral based on data from MDT-2113 (IN.PACT SFA Japan), under which 100 patients were enrolled across 11 sites and randomised treatment to either DCB (n=68) or standard percutaneous transluminal angioplasty (PTA) (n=32).
The results were found to be consistent with one-year findings from the pivotal IN.PACT SFA Trial. It showed a low clinically driven target lesion revascularisation (CD-TLR) rate and high-patency rate.
IN.PACT Admiral SFA Japan has reportedly demonstrated 93.9% primary patency in the DCB group compared to 46.9% in the PTA group at one year based on Kaplan-Meier Estimate.
Additionally, one-year results have shown a CD-TLR rate of 2.9% for the DCB group compared to 18.8% in the PTA group.
In IN.PACT SFA Japan, major adverse events were also found to be lower with 4.4% compared to 18.8% in the PTA group; p=0.028 for the DCB at one year, with no limb amputations or all-cause death in both treatment groups.
Results were also consistent with two-year findings from the IN.PACT SFA Trial.
Medtronic provides medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.