Medtronic In.Pact Admiral DCB Evaluated in Study Cohorts in Asia and Belgium

January 25, 2017—Medtronic announced that new data for its In.Pact Admiral drug-coated balloon (DCB) in patients with peripheral artery disease (PAD) were presented at LINC 2017, the Leipzig Interventional Course in Leipzig, Germany.

The company stated that real-world outcomes from regional cohorts of the IN.PACT Global Study in Asia and Belgium reinforce the strong efficacy and consistent outcomes of the In.Pact Admiral DCB across multiple patient populations.

Donghoon Choi, MD, presented 1-year results from the Asian subset of the IN.PACT Global Study, including data from 114 patients at six sites in South Korea and Singapore. The results continue to demonstrate the positive performance in both safety and efficacy for the In.Pact Admiral DCB in a broader set of complex patients with PAD.

According to Medtronic, in this subset analysis, the low rate (3.8%) of clinically driven target lesion revascularization (CD-TLR) at 1 year is consistent with the results in the complete cohort of 1,406 patients in the IN.PACT Global Study (7.5%). Results of the primary safety endpoint in the Asian cohort were also consistent with results from the full Global Study cohort, with 96.2% of patients achieving positive outcomes.

In a separate presentation of results from the IN.PACT Global Study, Koen Deloose, MD, presented data on 305 patients from seven sites in Belgium. Medtronic noted that Belgium was the first country to enroll patients in the study and represents the largest enrolling country. At 1 year, patients experienced positive outcomes based on both safety and efficacy measures, consistent with overall findings from the IN.PACT Global Study.

In this patient subset, the low CD-TLR rate at 1 year (7.6%) was also consistent with the results of the complete Global Study cohort (7.5%). Results of the primary safety endpoint were also in line with results from the full study, with 90.6% of patients achieving positive outcomes, reported Medtronic.

The In.Pact Admiral DCB is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of restenotic lesions with lengths up to 180 mm in superficial femoral or popliteal arteries with diameters of 4 to 7 mm.