October 16, 2008 - Lumen Biomedical Inc. said that Principal Investigator Subbarao V. Myla, M.D., presented the results from the EPIC clinical trial — “Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting” — at TCT 2008.
From March 2007 to May 2008, the multicenter, single-arm EPIC clinical trial evaluated the FiberNet Embolic Protection System during carotid artery stenting of 237 high surgical risk patients with a critical carotid artery stenosis. The EPIC trial was an FDA IDE clinical study sponsored by Lumen Biomedical Inc.
“EPIC’s superior results stand alone; FiberNet EPS embodies all three successful requirements for safe carotid stenting, low profile, optimal filtration and ease of use,” Dr. Myla said. “The FiberNet System represents the best blend of science and clinical practice finding the right balance of optimal filtration with maintained safe perfusion.”
The FiberNet EPS captures particles released during the carotid artery stenting procedure with a filter made of a 3-dimensional matrix of fibers. The filter is designed to prevent microscopic debris from traveling to the brain. After the particles have been captured, the FiberNet filter is then retrieved into the retrieval catheter, Lumen Biomedical’s FDA-cleared Xtract Aspiration Catheter, and removed from the patient.
The mean age of the patients participating in the clinical trial was 74 years (21 percent were octagenarians), 64 percent male and 20 percent were symptomatic.
Overall, the combined major adverse event rate at 30 days for all death, stroke and myocardial infarction (MI) was 3 percent. There were 5 strokes (4 ischemic and 1 hemorrhagic) for a 30-day stroke rate of 2.1 percent. There were no unanticipated adverse device effects. The results demonstrate that FiberNet EPS' unique features may contribute to a lower stroke rate during carotid artery stenting in high surgical risk patients.
For more information: www.lumenbio.com