A journal article was submitted detailing a study which sought to evaluate device effectiveness for femoropopliteal artery disease treatment; an analysis of k-vis ella registry.2,099 patients (2774 limbs) were included in the study.Femoropopliteal artery lesions were treated using either poba(n=826), bare metal stent (n=943), drug coated balloon (n=778), or drug eluting stent (=227).Two types of drug coated balloons were use, medtronic's inpact admiral dcb (78%) or a non-medtronic dcb.All endovascular procedures were performed by experienced interventional cardiologists; the decision for the use of each device was left to the discretion of the operator.Technical success was defined as revascularization of the target vessel with residual stenosis.After treatment with dcbs, in cases of angiographically confirmed flow-limiting dissection or residual stenosis greater than 30% ,provisional stenting with bms was performed.Technical success was achieved in over 97% of the limbs studied.Procedural complications in the dcb group included, distal embolization(1), vascular rupture (9), bleeding and in-hospital death(1).During follow-up 78 tlrs were required, 83 major adverse limb events occurred, 345 cases of loss of clinical patency and 38 cases of death.
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A2: average age.A3: majority sex.Https://doi.Org/10.1016/j.Jcin.2023.05.002.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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