Three-year results with the IN.PACT Admiral drug-coated balloon shows positive results in PAD.- Medtronic.

Medtronic announced new data that continues to reinforce the safety, durability, and consistency of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with peripheral arterial disease (PAD). 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 shows that the freedom from clinically-driven target lesion revascularization (CD-TLR) rate calculated using Kaplan Meier survival estimates was 76.9 percent in a real-world patient cohort with a mean lesion length of 12.09 � 9.54 cm, 18.0 percent in-stent restenosis, 35.5 percent occluded lesions, and 39.9 percent diabetic subjects.

Additionally, the proportion of patients undergoing repeat procedures were low through three years: major target limb amputations, 0.8 percent, and CD-TLR, 23.5 percent (n=1,406). The imaging cohort, which evaluated 926 DCB and 143 Percutaneous Transluminal Angioplasty (PTA) subjects, demonstrated a patency rate of 88.8 percent for IN.PACT Admiral compared to 53.9 percent for PTA (p<0.001) and a freedom from clinically-driven target lesion revascularization cd-tlr rate of 94.3 percent compared to 80.2 percent for pta p><0.001). additional safety and effectiveness outcomes from the dcb arm also included low rates of thrombosis 2.4 percent and cd-tlr 5.8 percent and no occurrences of major target limb amputation at one year.>

The propensity analysis (a subset of the imaging cohort) matched one PTA subject with up to four IN.PACT Admiral DCB subjects based on baseline variables (136 PTA subjects and 466 DCB subjects). The propensity-matched analysis showed a patency rate of 90.5 percent for the IN.PACT Admiral DCB as compared to 53.8 percent for PTA (p<0.001) and a freedom from cd-tlr rate of 96.9 percent compared to 80.7 percent for pta p><0.001). additional safety and effectiveness outcomes from the dcb arm also included low rates of thrombosis 1.6 percent and cd-tlr 3.3 percent and no occurrences of major target limb amputation at one year. data were presented at the cardiovascular and interventional radiological society of europe cirse annual meeting and the 30th transcatheter cardiovascular therapeutics tct conference.>