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Oct 18, 2020 | 16:20 EDT
Medtronic announced results from the IN.PACT BTK study, a feasibility study assessing the safety and effectiveness of the IN.PACT 0.014 drug-coated balloon in critical limb ischemia subjects with chronic total occlusion in the infrapopliteal arteries. The data were presented in the Late-Breaking Clinical Trial Sessions at TCT Connect, the 32nd annual scientific symposium of the Cardiovascular Research Foundation.The effectiveness endpoint evaluated nine-month late lumen loss, an angiographic measurement comparing the post-procedure lumen diameter with the lumen diameter at nine months, specifically sub-segmental late lumen loss, or lumen loss assessed along the entirety of the lesion; and classic late lumen loss, or lumen loss measured at the single narrowest segment of the artery. The safety endpoint evaluated a composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation within nine months, and freedom from clinically driven target limb revascularization within nine months post-index procedure. At nine months, subjects in the DCB group experienced a reduction in sub-segmental late lumen loss compared to those in the PTA control group, a 53% lower late lumen loss than the PTA control group. Using the classic late lumen loss method, subjects in the DCB group experienced lower late lumen loss compared to those in the PTA control group at nine months, a 32% lower late lumen loss than the PTA control group. There was no statistical difference in the safety composite endpoint within nine months between the DCB group and PTA control group. The IN.PACT 0.014 DCB is an investigational device that is being evaluated in Europe. This device is not currently being evaluated in the United States.