Invatec launches a 3-dimensional distal Embolic Protection System for Carotid Artery Stenting

Invatec, a comprehensive innovator of interventional products, today introduced FiberNet^®, a 3-dimensional distal Embolic Protection System (EPS) for Carotid Artery Stenting with the lowest crossing profile (0.031’’) and highest performance capabilities on the market, manufactured by Lumen Biomedical. FiberNet provides superior deliverability and can be used in vessels ranging from 3.5 to 7 mm.

With its unique design, FiberNet ensures excellent atraumatic wall apposition. It is also usable in the most complex vasculature formations, captures micro-emboli as small as 40µm via specially shaped PET-fibers and can aspirate these emboli from the body, allowing for safe and easy retrieval.

The FiberNet Embolic Protection System was evaluated in the EPIC Trial, a multi-center clinical study during carotid artery stenting of 237 high surgical risk patients with critical artery stenosis demonstrating a 30-day stroke rate of 2.1%, the lowest ever reported for a distal Embolic Protection Device. The FiberNet EPS captures micro-emboli to prevent fragments traveling to the brain thus reducing the risk of ischemic stroke. Andrea Venturelli and Stefan Widensohler, co-founders of Invatec commented, “We are extremely excited about bringing this advancement in embolic protection technology to the worldwide market and believe it sets a new performance standard for distal embolic protection of Carotid Artery Stenting, further reducing the risk to the patient. Our partnership with Lumen represents a tremendous opportunity to expand our position in the endovascular field.”

“The FiberNet EPS has several attributes including ease of use, low profile, and the ability to conform to an irregular surface in the vessel wall, all of which have contributed to the impressive results and safety profile that we observed in the EPIC trial,” commented Dr. Subbarao Myla, medical director of cardiovascular research and endovascular intervention at Hoag Memorial Hospital in California and national principle investigator for the trial. “The device achieved the lowest stroke rate of any filter currently available, making FiberNet a top choice for physicians, and representing the next generation in embolic protection.”