New distal embolic protection device the FiberNet 3 dimensional filter: first carotid human study.
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 microm 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 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.


CONCLUSIONS
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 microm. The feasibility of the FiberNet has been demonstrated. Additional patients will demonstrate the overall safety and efficacy of this new EPD device.
Henry
Michel
M
Cabinet de Cardiologie, 54000 Nancy, France.
Polydorou
Antonios
A
Henry
Isabelle
I
Liasis
Nikos
N
Polydorou
Adamantia
A
Polydorou
Victoria
V
Demesticha
Theano
T
Skandalakis
Panayiotis
P
Kotsiomitis
Evaggelos
E
Hugel
Michel
M
Sedgewick
Jerry
J
Ruth
George
G
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000295:instrumentation*; D016893:Carotid Stenosis / Q000150:complications / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D002560:Cerebrovascular Circulation; D020878:Device Removal; D005240:Feasibility Studies; D005260:Female; D005374:Filtration / Q000295:instrumentation*; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000473:pathology / Q000503:physiopathology / Q000517:prevention & control*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome