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Zhao r, duan g, yang p, et al.Endovascular aneurysm treatment with the numen coil embolization system: a prospective randomized controlled open-label multicenter noninferiority trial in china.World neurosurgery.2022;160:e23-e32.Doi:10.1016/j.Wneu.2021.11.067 medtronic literature review found a report of patient complications in association with axium coils.The purpose of this article was to investigate the safety and efficacy of the numen coil compared with the axium coil in the treatment of intracranial systems.The study was a prospective randomized controlled open-label noninferiority trial (catch - coil application trial in china) conducted in 10 centers across china, and patients who fulfilled the inclusion and exclusion criteria were randomized 1:1 to either the test group (numen) or a control group (axium).The primary outcome was based on successful aneurysm occlusion at 6 months follow-up, whereas secondary outcomes included technical success, the recanalization and retreatment rates, and the rate of serious adverse events (saes) at 6 months and 12 months follow-up.Complete occlusion was defined as an aneurysm occlusion degree with a raymond score of i, whereas the recanalization rate was defined as the percentage of patients with a decreased aneurysm occlusion degree at the follow-up period compared with the immediate postoperative period.The safety outcome measurements included the retreatment rate as well as the clinical outcome worsening rate at and 12 months postoperatively and procedure-related or device-related adverse events at 30 days and 6 and 12 months after the treatment, whereas the clinical outcome worsening rate was defined as the proportion of patients with a modified rankin scale score >2 with greater than or equal to 1 point higher than the preprocedural score.The obtained evaluation results were the final score of those patients who had not completed either 6 or 12 months of follow-up because of death or saes related to the surgical procedure or the treatment device.A total of 334 enrolled catch trial patients¿ data were included in the full analysis set (fas), except for 16 patients who were excluded because of withdrawal of informed consent (5 patients), nonconformance with inclusion and exclusion criteria (8 patients), and nonuse of the coil (3 patients) according to their random allocation.There were 166 subjects in the axium control group that underwent all necessary procedures.There were 108 female patient's and 58 males.The mean age was 56.15 years.Medical history of these subjects included 28 with cerebral infarction, 10 with coronary artery disease, 88 with hypertension, 13 with hypercholesterolemia, 12 with diabetes, 32 with current/previous smoking, and 23 with current/previous drinking.The article does not state any technical issues during use of the axium coils.The following intra- or post-procedural outcomes were noted: -the incidence of saes during the 12 months follow-up period was 29/166 patients.Incidence of procedure-related saes was 12/166. device related saes incidence was 6/166.Neurological complications were experienced in 16/29 patients; symptomatic intracranial hemorrhage was experienced by 2/166 patients, aneurysm rupture or rebleeding experienced by 1/166 patients, symptomatic cerebral infarction by 10/166 patients, and other (e.G., hydrocephalus) by 3/166 patients. 22 patients in the control group with an incidence of 13.25% during the 12 months follow-up had procedure-related adverse events.-primary outcome data based on core laboratory data sets were available for 135 patients (pps) in the control group because the successful occlusion 124/135 in the control group.11/135 patients did not have successful occlusion at 6-months.Outcomes at 6 months follow-up were available for 135 patients, the complete occlusion rate was 77/135; 58/135 did not have complete occlusion. core laboratory angiographic outcomes at 12 months follow-up were available for 125 of axium group patients; the complete occlusion rate was 82/125 and 43/125 did not have complete occlusion.The recanalization rate (follow-up at 6 months) was 7/129 patients.-at 6 months follow-up, 2/160 patients in the control group accepted retreatment.At the 12 months follow-up, 2 patients in the control group accepted retreatment -clinical outcome worsening rate was 8/164 in the axium control group.Clinical follow-up data at 12 months available for 319 patients, the clinical outcome worsening was 8/159.
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Zhao r, duan g, yang p, et al.Endovascular aneurysm treatment with the numen coil embolization system: a prospective randomized controlled open-label multicenter noninferiority trial in china.World neurosurgery.2022;160:e23-e32.Doi:10.1016/j.Wneu.2021.11.067 a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.See manufacturer report #2029214-2022-02044 for another event from this article.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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