Medtronic received a journal article titled 'retrospective review of directional atherectomy and drug-coated balloon use in a pad safety net population'.It reports a retrospective, observational, cohort study through chart review of patients who underwent da and dcb during ler for pad from april 2016 to january 2022.Hawkone was the directional atherectomy device used for all cases and inpact admiral was the dcb used in all cases.The analysis included 58 patients and reported that the combination of da and dcb was efficacious, resulting in low rates of bailout stenting (16%) and target vessel revascularisation (26%) at 2 years.Low complication rates were reported, tibial embolism (12%) and vessel perforation (25%).
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Title: retrospective review of directional atherectomy and drug-coated balloon use in a pad safety net population authors: shea e.Hogan, matthew holland, joseph burke, paisley johnson, demetria mcneal, lisa cicutto, mark nehler, pamela n.Peterson journal: journal of invasive cardiology reference: 2023;35(4):e205-e216 a2=average age a3=majority sex: male (59%) a5a=majority ethnicity: not hispanic/latino (69%) a5b =majority race: white (72%) 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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