Drug-coated balloon (DCB) demonstrates consistent clinical outcomes in peripheral artery disease (PAD).
Medtronic has announced clinical evidence supporting the IN.PACT Admiral drug-coated balloon (DCB) demonstrating durable and consistent clinical outcomes in peripheral artery disease (PAD). The new data included the two-year results from the MDT-2113 study (IN.PACT SFA Japan) and data from a critical limb ischemia (CLI) subgroup analysis from the IN.PACT Global Study. The study enrolled 100 patients across 11 sites in Japan and randomized treatment to either DCB (n=68) or plain balloon angioplasty (PTA) (n=32). The results were consistent with two-year findings from the pivotal IN.PACT SFA Study, showing a low clinically-driven target lesion revascularization (CD-TLR) rate and high patency rate.
IN.PACT Admiral SFA Japan demonstrated 79.8 percent primary patency in the DCB group as compared to 46.9 percent in the PTA group at two years based on Kaplan-Meier Estimate. The two-year results also demonstrated a CD-TLR rate of 9.1 percent for the DCB group compared to 20.7 percent in the PTA group and a freedom from CD-TLR based on Kaplan-Meier Estimate of 90.8 for the DCB group compared to 81.3 percent in the PTA group. In IN.PACT SFA Japan, major adverse events were also lower for the DCB at two years (15.2 percent compared to 24.1 percent in the PTA group, with no major target limb amputations. There were no additional safety concerns at two years. The data were presented at the Leipzig Interventional Course (LINC).
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