The Fridley, Minn.-based released data from 3 different studies of its In.Pact Admiral DCB at the 2016 Charing Cross Symposium meeting in London, including 1-year results from a chronic total occlusion imaging cohort and 2-year gender and diabetic subgroup analysis.
“The In.Pact Admiral drug-coated balloon’s unique coating delivers paclitaxel in a solid state which results in durable tissue levels of drug leading to prolonged anti-restenotic effect. We have 1st-of-its-kind data that shows it continues to do so even in the more challenging cases and patient populations. These data continue to position the In.Pact Admiral drug- coated balloon as a durable treatment option for femoropopliteal interventions,” In.Pact SFA trial principal investigator Dr. Peter Schneider of Honolulu’s Kaiser Medical Center said in a press release.
Data from a chronic total occlusion imaging cohort of 126 patients with average lesion lengths of 22.9 cm indicated an 84.4% primary patency rate and 12.2% rate of clinically driven target lesion revascularization. The data came from the 1,535 patient, 27-country In.Pact global study, Medtronic said.
Additional data indicated a 4.3% rate of all-cause mortality, a 4.3% rate of thrombosis and no major target limb amputations, Medtronic said.
“Despite the complexity of these challenging and complex long chronic total occlusion lesions, the outcomes were excellent and remarkably consistent to that of the overall cohort. These results show the effectiveness of the In.Pact Admiral drug-coated balloon as a primary treatment in this complex lesion subset,” Dr. Gunnar Tepe of Rosenheim, Germany’s RoMed Klinikum said in a prepared statement.
A separate presentation presented data from a gender and diabetes analysis cohort from the In.Pact SFA trial, which examined females and patients with diabetes. Data from a cohort of 113 female patients, from a total of 331 patients enrolled in the trial, returned a 76.7% rate of primary patency at 2 years, compared to 42.3% in patients treated with balloon angioplasty.
Data from the female cohort indicated a 13.2% rate of clinically-driven target lesion revascularization, compared to 38.2% in the balloon angioplasty arm. Beneficial treatment effects in the female population were consistent with the male population, Medtronic said.
A separate evaluation of patients with diabetes indicated similar results between those without diabetes, with primary patency rates of 73.3% in patients with diabetes and 82.5% in patients without. In the balloon angioplasty arm, data from patients with diabetes indicated a 45.8% rate of primary patency, and 54.5% for those without diabetes. Diabetes patients reported a 10.7% rate of CD-TLR and those without diabetes returned an 8.1% rate of CD-TLR.
The company touted data from a pre-clinical study of complex anatomies, saying the coating of the device demonstrated “sustained paclitaxel in tissue over time, facilitating an extended retention of drug in tissue available for a sustained anti-restenotic effect.”
“The rigor, volume and cadence of strong clinical data along with the consistency of data for the In.Pact Admiral drug-coated balloon are among the best for any anti-restenotic therapy available for the treatment of symptomatic superficial femoral artery disease. When evaluating quality of study data, it’s important to consider the clinical rigor built into the study design. This is why Medtronic has made a significant investment in rigorous independent core lab adjudication for the In.Pact clinical program to deliver unquestionable results,” aortic & peripheral vascular biz medical director Dr. Mark Turco said in a prepared release.