Patients who had stents implanted utilizing the FiberNet Embolic Protection System, during carotid stenting with commercial stents, showed a low number of cardiac problems.
Led by Subbarao Myla, MD, Medical Director CV Research and Vascular Intervention, Hoag Memorial Hospital, Newport Beach, Calif., the study focused on patients who were at high risk for CEA that were treated with the FiberNet Embolic Protection System during carotid artery stenting procedures.
The data was compiled into a registry that tracked 237 patients at 26 sites across the U.S.
Myla said that the system uses a unique filter design with low porosity.
"Its easy-to-use features combined with aspiration prior to retrieval lead to low event rates. The FiberNet system allows blood flow during the procedure, a fiber-based filter captures particles as small as 40 µm and the stent is delivered for placement using a standard coronary guide wire," he said.
In the study, patients at high-risk for CEA were treated in a prospective, multi-center, non-randomized trial.
Key exclusion criteria included planned treatment of contra-lateral carotid within 30 days, stroke within 48 hours, myocardial infarction (MI) within 14 days, total occlusion, stenosis unsuitable for carotid stenting and serial lesions that require more than one stent.
The EPIC study revealed very low stroke, MI and death rates using the FiberNet embolic protection system during carotid stenting.
The study, titled "EPIC: Evaluating the Use of the FiberNet® Embolic Protection System in Carotid Artery Stenting," was reported during the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.