New distal embolic protection device the FiberNet® 3 dimensional filter: First carotid human study
- 25 May 2007
- journal article
- clinical trial
- Published by Wiley in Catheterization and Cardiovascular Interventions
- Vol. 69 (7), 1026-1035
- https://doi.org/10.1002/ccd.21129
Abstract
Objective: Evaluate the performance and safety of the FiberNet® Embolic Protection System during carotid artery intervention. Background: Carotid 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). Methods: The 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 μm without compromising flow. Results: 35 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 mm2 (37.7–107.5). Comparisons were made with other EPDs. The mean surface area of debris caught was 12.2 mm2 (2.7–34.3). No changes were noted in CT/MRI at 30‐day post procedure. Conclusion: The 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 μm. The feasibility of the FiberNet has been demonstrated. Additional patients will demonstrate the overall safety and efficacy of this new EPD device.Keywords
This publication has 63 references indexed in Scilit:
- Cerebral Ischemia After Carotid InterventionJournal of Endovascular Therapy, 2004
- Comparison of 4 Cerebral Protection Filters for Carotid Angioplasty:An In Vitro Experiment Focusing on Carotid AnatomyJournal of Endovascular Therapy, 2004
- Protected Carotid StentingStroke, 2003
- Early Outcome of Carotid Angioplasty and Stenting With and Without Cerebral Protection DevicesStroke, 2003
- Cerebral Protection During Carotid Artery StentingStroke, 2002
- Role of the Distal Balloon Protection Technique in the Prevention of Cerebral Embolic Events During Carotid Stent PlacementStroke, 2001
- Silent Cerebral Ischemia Detected by Diffusion-Weighted MRI After Carotid EndarterectomyStroke, 2000
- Carotid Stent-Supported Angioplasty: A Neurovascular Intervention to Prevent StrokeThe American Journal of Cardiology, 1996
- Efficacy of Carotid Endarterectomy for Asymptomatic Carotid StenosisNew England Journal of Medicine, 1993
- MRC European Carotid Surgery Trial: interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosisThe Lancet, 1991