A Medical Device Daily
Lumen Biomedical (Plymouth, Minnesota) said its FiberNet Embolic Protection System (EPS) has received FDA clearance for the treatment of patients receiving endovascular intervention for carotid artery disease. The approval follows the recent release of EPIC clinical study data demonstrating the lowest stroke rates of any filter currently available on the U.S. market.
The FiberNet EPS captures debris released during the stenting procedure and prevents it from traveling to the brain, where it has the potential to cause a stroke.
Lumen says that the defining attribute of the FiberNet filter lies in the 3-D design, comprised of a matrix of fibers, allowing for better capture efficiency. The low-profile filter is mounted on a guide wire, needing no delivery system to cross the lesion.
Remote actuation deploys the fiber-based filter – treating vessels ranging from 3.5 mm to 7.0 mm – filling the vessel and ensuring "excellent wall apposition," according to the company. After the particles have been captured, the FiberNet filter is retrieved into the retrieval catheter under aspiration, and removed from the patient.
"We are pleased to bring this proven technology to the U.S. market," said CEO Matthew Ogle. "The effective design of the filter providing excellent patient outcomes set this system apart from other protection options currently available; further supporting carotid stenting as an alternative to surgery."