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news.Lumen Biomedical, a developer of interventional devices, has announced that the FDA has cleared its FiberNet embolic protection system for the treatment of patients receiving endovascular intervention for carotid artery disease.
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The approval follows the recent release of the Epic clinical study data demonstrating the lowest stroke rates of any filter currently available on the US market.
The FiberNet embolic protection system captures debris released during the stenting procedure and prevents it from traveling to the brain, where it has the potential to cause a stroke. The defining attribute of the FiberNet filter lies in the three-dimensional design, comprised of a matrix of fibers, allowing for better capture efficiency, the company said.
The FiberNet embolic protection system was evaluated in the multi-center, Epic trial during carotid artery stenting of 237 high surgical risk patients with a critical carotid artery stenosis
Matthew Ogle, CEO of Lumen Biomedical, said: “We are pleased to bring this proven technology to the US market. 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.”