Medtronic presents 3-year peripheral arterial disease data

Medtronic announced data that continues to reinforce the safety, durability, and consistency of the IN.PACT Admiral drug-coated balloon in real-world patients with peripheral arterial disease. Three-year real-world results from the full clinical cohort of the IN.PACT Global Study and one-year data from the Total IN.PACT pooled imaging and propensity analyses were presented at the Cardiovascular and Interventional Radiological Society of Europe annual meeting and the 30th Transcatheter Cardiovascular Therapeutics conference, the annual scientific symposium of the Cardiovascular Research Foundation, respectively. The freedom from clinically-driven target lesion revascularization rate calculated using Kaplan Meier survival estimates was 76.9% in a real-world patient cohort with a mean lesion length of 12.09 +/- 9.54 cm, 18.0% in-stent restenosis, 35.5% occluded lesions, and 39.9% diabetic subjects. Additionally, the proportion of patients undergoing repeat procedures were low through three years. Total IN.PACT combined independently adjudicated data from a total of 1,837 patients treated with IN.PACT Admiral DCB from all IN.PACT Admiral randomized clinical trials and real-world studies from 147 sites across 28 countries. The analyses presented today at TCT specifically looked at two different groups – a core laboratory-adjudicated imaging cohort and a propensity matched imaging cohort. The data showed that IN.PACT Admiral DCB demonstrated consistently superior patency and freedom from clinically-driven target lesion revascularization compared to standard PTA alone. The propensity analysis matched one PTA subject with up to four IN.PACT Admiral DCB subjects based on baseline variables. The propensity-matched analysis showed a patency rate of 90.5% for the IN.PACT Admiral DCB as compared to 53.8% for PTA and a freedom from CD-TLR rate of 96.9% compared to 80.7% for PTA. Additional safety and effectiveness outcomes from the DCB arm also included low rates of thrombosis and CD-TLR, and no occurrences of major target limb amputation at one year.

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