Analyses Support Use Of FiberNet® Embolic Protection System In Carotid Artery Stenting Of High Surgical Risk Patients

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Medical Devices / Diagnostics
Article Date: 17 Oct 2008 - 7:00 PDT

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Lumen Biomedical, Inc., a Minnesota-based medical device company, announced today 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, during the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, in Washington DC. The presentation was held Thursday, October 16, 2008 as part of "The Late Breaking First Report Investigations" in the Main Arena.

From March 2007 to May 2008, the multi-center, single-arm EPIC clinical trial evaluated the FiberNet® Embolic Protection System (EPS) during carotid artery stenting of 237 high surgical risk patients with a critical carotid artery stenosis. The EPIC trial was a 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" said Dr. Myla. "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 highly-effective 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% were octagenarians), 64% male and 20% were symptomatic.

Overall, the combined major adverse event rate at 30 days for all death, stroke and myocardial infarction (MI) was 3.0%. There were five strokes (4 ischemic and 1 hemorrhagic) for a 30 day stroke rate of 2.1%. 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.

"Results from the EPIC trial confirm Lumen Biomedical has set the bar for the next generation of embolic protection devices," said Matthew Ogle, Chief Executive Officer of Lumen Biomedical, Inc. "As the market continues to yield positive data and engineer superior product advancements, it will provide the fuel to further propel the growth of carotid stenting worldwide."

ABOUT LUMEN BIOMEDICAL, INC.:

Lumen Biomedical is driven towards the development and commercialization of unique interventional devices for use in multiple anatomical areas where embolic protection or thrombus removal may be required. These markets include peripheral vascular and coronary applications with potentials approaching 1.6 billion worldwide. To learn more about Lumen Biomedical, Inc. visit the web site at http://www.lumenbio.com.

Cautionary Statement Regarding Forward Looking Statements
These forward-looking statements are based upon beliefs and estimates using information available to us at present, and do not provide guarantees as to the future events or performance of our company or our products. The FiberNet® Embolic Protection System used in the EPIC trial are investigational for the patient population studied; their use is limited by federal (or United States) law. Readers are cautioned not to place undue reliance on any of our forward-looking statements.