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January 2008
Sponsored by Lumen Biomedical, Inc.
FiberNet® Embolic Protection System
Exploring the differences.
Exploring the differences.
Produced under an educational grant from Lumen Biomedical, Inc.
As the performance of carotid artery stenting (CAS) becomes more common among interventionists, new generations of embolic protection technologies are emerging. With the challenges of patient selection and the curve of operator experience, developing reliability and flexibility in embolic protection is a vital component of the procedure.
This article reviews the design and features of the FiberNet Embolic Protection System (EPS) (Lumen Biomedical, Inc., Plymouth, MN), which received foreign certification (CE Mark) and is currently in ongoing US clinical trials. The second portion of the article includes a panel of key physicians discussing their initial experiences using the FiberNet EPS.
DESIGN: THREE-DIMENSIONAL MESHWORK OF POLYMERIC FIBERS
Lumen Biomedical's FiberNet captures debris as small as 40 µm within a three-dimensional filter made of hundreds of PET (polyethylene terephthalate) fibers.
DELIVERY: GUIDEWIRE MOUNTED
The FiberNet is mounted on a .014-inch guidewire with a crossing profile ranging from 1.7 to 2.9 F. No delivery system is required to advance the undeployed filter through the lesion (Figure 1).
LANDING ZONE
The FiberNet gives the operator more flexibility with placement and positioning in curved segments, requiring a small landing zone (1.5 cm minimum).
VESSEL SIZING: WALL APPOSITION
The fiber-based design of the filter conforms to asymmetrical vessels (Figure 2). The five FiberNet sizes fill vasculatures ranging from 1.75 to 7.0 mm.
FILTER RETRIEVAL: XTRACT CATHETER
The FiberNet filter is then removed through the single-lumen design of the Xtract aspiration catheter (Lumen Biomedical) supplied with the system.
ENHANCED RADIOPAQUE MARKER BANDS
FiberNet offers a unique dual marker band design, providing direct visual confirmation of filter deployment (Figures 3 and 4).
AREAS OF CLINICAL STUDY
Ongoing clinical trials for the FiberNet EPS include the EPIC trial for CAS, the RETRIEVE trial for saphenous vein graft stenting, and the FORTRESS trial for renal artery stenting (initiated by VIVA Physicians, Inc.).
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