Lumen's FiberNet EPS for CAS Shows Success in EPIC Study

March 1, 2010—The Society for Cardiovascular Angiography and Interventions announced that the multicenter EPIC (FiberNet Embolic Protection System [EPS] in Carotid Artery Stenting [CAS] Trial) study found that the FiberNet EPS (Lumen Biomedical, Inc., Maple Grove, MN) had a 97.5% success rate when used in patients undergoing CAS. Subbarao Myla, MD, et al published the findings online ahead of print in Catheterization and Cardiovascular Interventions.

The EPIC investigators evaluated the safety and efficacy of the FiberNet EPS for embolic protection during CAS. The study was designed to demonstrate that the 30-day major adverse event rate of all death, stroke, and myocardial infarction is significantly less than the performance goal of 8.3% from the ARCHER 3 results published by William A. Gray, MD, et al in the Journal of Vascular Surgery (2006;44:258–268).

The EPIC trial enrolled 237 patients with a mean age of 74 years from 26 centers across the United States and Europe. Study participants were 64% men, and 20% had symptomatic carotid artery disease (CAD). Results indicate the combined major adverse event rate at 30 days after carotid endarterectomy for all death, stroke, and heart attack was 3%. Dr. Myla stated that that rate is encouraging. The EPIC investigators concluded that the FiberNet EPS, when used with commercially available stents, produced low stroke rates after CAS in high-surgical risk patients with CAD.

Describing the EPIC investigators' experience with the FiberNet device, Dr. Myla commented, “The low crossing profile and integration of a primary guidewire shortened procedure time and facilitated lesion crossing and filter placement, especially in the presence of tortuous anatomy. The 0.014-inch guidewire tip demonstrated good torque response, and the guidewire provided excellent support. It was ideal for procedures in which tortuosity would preclude placement of a more structured distal protection device with a stiff delivery catheter. Conformability of the expanded fiber network to the vessel wall and the short landing zone of the device made it ideal for challenging anatomy distal to the lesion. Anecdotally, investigators have commented that the FiberNet EPS resulted in fewer vessel spasms.”