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Catheter Cardiovasc Interv · Jun 2007
Clinical TrialNew distal embolic protection device the FiberNet 3 dimensional filter: first carotid human study.
- Michel Henry, Antonios Polydorou, Isabelle Henry, Nikos Liasis, Adamantia Polydorou, Victoria Polydorou, Theano Demesticha, Panayiotis Skandalakis, Evaggelos Kotsiomitis, Michel Hugel, Jerry Sedgewick, and George Ruth.
- Cabinet de Cardiologie, 54000 Nancy, France.
- Catheter Cardiovasc Interv. 2007 Jun 1; 69 (7): 1026-35.
ObjectiveEvaluate the performance and safety of the FiberNet Embolic Protection System during carotid artery intervention.BackgroundCarotid Angioplasty and Stenting (CAS) can be proposed to treat the majority of carotid stenoses. Brain embolization takes place and routine use of Embolic Protection Devices (EPD) is warranted. Many EPDs have significant limitations, which may be addressed by a new EPD, the FiberNet (Lumen Biomedical, Plymouth, MN).MethodsThe system consists of a 3-dimensional expandable filter made of fibers, which expand radially, mounted onto a 0.014'' wire and retrieval catheter. FiberNet can capture particles as small as 40 microm without compromising flow.Results35 lesions treated in 34 patients. Male 67.6%. Age: 71.4 +/- 8.8 (50-85). Average stenosis 84.5% +/- 7.9 (70-99). 29.4% were symptomatic. Technical success: 34/35 (97%). No stroke or death within 30 days. Neurological events: two permanent amaurosis, one amaurosis fugax. All samples visually contained significant amounts of emboli. The mean surface area of debris caught was 63.8 mm(2) (37.7-107.5). Comparisons were made with other EPDs. The mean surface area of debris caught was 12.2 mm(2) (2.7-34.3). No changes were noted in CT/MRI at 30-day post procedure.ConclusionThe first human use of this new novel EPD in carotid artery stenting is encouraging. The FiberNet was easy to use and confirmed the ability to capture particles less than 100 microm. The feasibility of the FiberNet has been demonstrated. Additional patients will demonstrate the overall safety and efficacy of this new EPD device.
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