A2: average age a3: majority sex literature ref: 10.1016/j.Avsg.2023.01.043 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Medtronic received a literature article titled 'drug-coated balloons vs.Drug-eluting stents for treatment of long femoropopliteal lesions'.282 consecutive patients (177 dcb and 105 des) satisfied the enrolment criteria.After propensity score stratification, 228 patients (139 men; median age 69 years) were included in the study:131 patients who were treated with dcb and 97 with des.In the dcb group, in.Pact admiral and in.Pact pacific balloons were used exclusively.In the des group, patients were treated a non medtronic nitinol stent with a polymerfree paclitaxel coating.The choice of the dcb type (in.Pact pacific or in.Pact admiral), access site (contralateral vs.Antegrade), and predilation with an undersized, uncoated balloon was left to the discretion of the operator.In the dcb cohort 100 (76.3%) of the 131 lesions were predilated, and provisional stent placement was performed in 24 (18.3%) lesions for refractory stenosis (5, 3.8%), flowlimiting dissection (13, 9.9%), and other reasons (6, 4.6%).The binary restenosis rates were 23.9% (26/109) in the dcb; the clinically driven tlr rates were 15.6% (17/109) vs.Any tlr 19.0% (15/79,).There was no procedure related mortality in either cohort.
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