Peripheral Vascular Disease
New 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 BA,
George Ruth DVM, PhD,
Corresponding Author
Michel Henry
Cabinet de Cardiologie, 54000 Nancy, France
Global Research Institute, Apollo Clinic, Hyderabad, India
80, rue Raymond Poincaré, 54000 Nancy, FranceSearch for more papers by this authorAntonios Polydorou
Panteleimon General Hospital, Athens, Greece
Search for more papers by this authorIsabelle Henry
Polyclinique Bois-Bernard, 62 320 Bois-Bernard, France
Search for more papers by this authorAdamantia Polydorou
Alexander S. Onassis Public Benefit Foundation, Greece
Search for more papers by this authorVictoria Polydorou
Panteleimon General Hospital, Athens, Greece
Search for more papers by this authorPanayiotis Skandalakis
Department of Anatomy, University of Athens, Greece
Search for more papers by this authorEvaggelos Kotsiomitis
Department of Anatomy, University of Athens, Greece
Search for more papers by this authorMichel Hugel
Cabinet de Cardiologie, 54000 Nancy, France
Global Research Institute, Apollo Clinic, Hyderabad, India
Search for more papers by this authorJerry Sedgewick BA
University of Minnesota, Biomedical Department, Minnesota, USA
Search for more papers by this authorGeorge Ruth DVM, PhD
University of Minnesota, Biomedical Department, Minnesota, USA
Search for more papers by this authorMichel Henry,
Antonios Polydorou,
Isabelle Henry,
Nikos Liasis, Adamantia Polydorou,
Victoria Polydorou,
Theano Demesticha, Panayiotis Skandalakis,
Evaggelos Kotsiomitis,
Michel Hugel,
Jerry Sedgewick BA,
George Ruth DVM, PhD,
Corresponding Author
Michel Henry
Cabinet de Cardiologie, 54000 Nancy, France
Global Research Institute, Apollo Clinic, Hyderabad, India
80, rue Raymond Poincaré, 54000 Nancy, FranceSearch for more papers by this authorAntonios Polydorou
Panteleimon General Hospital, Athens, Greece
Search for more papers by this authorIsabelle Henry
Polyclinique Bois-Bernard, 62 320 Bois-Bernard, France
Search for more papers by this authorAdamantia Polydorou
Alexander S. Onassis Public Benefit Foundation, Greece
Search for more papers by this authorVictoria Polydorou
Panteleimon General Hospital, Athens, Greece
Search for more papers by this authorPanayiotis Skandalakis
Department of Anatomy, University of Athens, Greece
Search for more papers by this authorEvaggelos Kotsiomitis
Department of Anatomy, University of Athens, Greece
Search for more papers by this authorMichel Hugel
Cabinet de Cardiologie, 54000 Nancy, France
Global Research Institute, Apollo Clinic, Hyderabad, India
Search for more papers by this authorJerry Sedgewick BA
University of Minnesota, Biomedical Department, Minnesota, USA
Search for more papers by this authorGeorge Ruth DVM, PhD
University of Minnesota, Biomedical Department, Minnesota, USA
Search for more papers by this authorAbstract
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. © 2007 Wiley-Liss, Inc.
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