Ref: doi: 10.1177/1526602820915244.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Medtronic received a literature article titled 'two-year outcomes of orbital atherectomy combined with drug-coated balloon angioplasty for treatment of heavily calcified femoropopliteal lesions'.63 patients were treated with dcb ( drug coated balloon) and 50 patients were treated with oa+dcb (orbital atherectomy + drug coated balloon) all the interventions were performed by 3 operators using a treatment strategy for oa+dcb that was similar to a previous study.21 lesions were crossed with a 0.018- or 0.035- inch guidewire, followed by exchange using a support catheter or balloon for a wire and the peripheral oa system (non-medtronic).Oa runs were performed with low, medium, or high speed, based on the lesion characteristics and vessel size, in order to optimize the angiographic outcome.In general, a crown size of 1.5 mm was used for popliteal lesions and a 2.0-mm crown for femoral lesions.The number of passes performed and the use of distal embolic protection were at the discretion of the operator.When embolic protection was used (non-medtronic) was utilized.After oa, dcb angioplasty was performed using the in.Pact admiral balloon (medtronic) inflated at 8 atmospheres for 3 minutes, with the dcb sized 1:1 to the reference vessel.In cases where a suboptimal angiographic result was achieved or a complication (eg, flow-limiting dissection) occurred, adjunctive therapy including bailout stenting was performed at the operator¿s discretion.The general approach in these cases was to stent only the affected area rather than the entire lesion.The stent type used in such cases was the interwoven nitinol stent (non-medtronic).Procedural success was similar at 70% in both groups, and there were no differences in the angiographic complications.Two year follow up reported 2 deaths in the dcb group and 6 deaths in the oa+dcb.
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