CUPERTINO, Calif., Sept. 29 /PRNewswire/ -- EndoTex Interventional Systems today announced preliminary 30-day results of the CABERNET trial, a study designed to evaluate the safety and efficacy of carotid artery stenting (CAS) as a minimally invasive alternative for treating carotid artery disease in patients ineligible or at high risk for surgery. L. Nelson Hopkins, M.D., Principal Investigator of the CABERNET trial, Professor & Chairman of Neurosurgery at the Buffalo State University presented at the Cardiovascular Research Foundation's (CRF) Sixteenth Annual Scientific Symposium, Transcatheter Cardiovascular Therapeutics (TCT 2004), in Washington D.C.
The carotid stenting trial, known as CABERNET, examines the use of EndoTex's NexStent(TM) Carotid Stent and Boston Scientific's FilterWire EX(TM) and EZ(TM) Embolic Protection Systems for treating patients who are at high-risk for carotid endarterectomy (CEA), the surgical treatment for carotid artery disease. CABERNET is a prospective, multi-center registry that enrolled a total of 488 symptomatic and asymptomatic patients at 15 U.S. and 4 O.U.S. clinical sites.
"We are encouraged by the 30-day results of the CABERNET trial, to demonstrate the safety and efficacy of the NexStent Carotid Stent and Boston Scientific FilterWire EX and EZ as a minimally invasive system to treat carotid artery disease. We are confident that the performance of this unique and novel system will be reinforced as we continue to collect results for our one year endpoint," said Joseph Tartaglia, President & CEO of EndoTex Interventional Systems.
"Boston Scientific's involvement with EndoTex continues to be an extremely successful collaboration," said Matthew Jenusaitis, President of Boston Scientific's Peripheral Interventions business. "The combination of both companies' technologies potentially provides a greater variety of innovative treatment options for patients with carotid artery disease."
In patients enrolled in the study, the 30-day composite major adverse event (MAE) rate, defined as all-cause stroke, death and myocardial infarction (MI) -- was 3.8 percent. This corresponds to a per-patient breakdown of MAE events to include: death, 0.5 percent; stroke, 3.4 percent; and MI, 0.2 percent, and compares favorably to other high-risk carotid artery stenting trials. The NexStent device success, defined as successful delivery and placement of the stent at the intended target site was 96.9 percent. The device success for the FilterWire EX and EZ, defined as FilterWire successfully placed within the target vessel, was 99.1 percent. Both reported device success rates correspond to a per-patient assessment. The one-year primary endpoint CABERNET results will be available mid to late 2005.
"It is exciting to see that with the release of each of the subsequent carotid stenting trial results, the outcomes appear to demonstrate continued improvement," said Principal Investigator L. Nelson Hopkins, M.D. "The results from CABERNET suggest that CAS in this high-risk patient subset appears competitive with the major CEA trials."
The NexStent Carotid Stent is a flexible, self-expanding nitinol (nickel-titanium alloy) stent. One stent size is used for treating vessel diameters ranging from 4 mm to 9 mm. The stent is a thin, flexible mesh that expands to appose the arterial wall of tapered or non-tapered vessel segments. The NexStent delivery system used in the CABERNET trial was a 5F, over-the-wire delivery system. This low profile system can deliver a stent capable of covering a 9mm reference vessel diameter.
The FilterWire EZ(TM) System is a low-profile embolic filter mounted on a 0.014" guide wire that is delivered through a monorail exchange delivery catheter. The FilterWire EX System is Boston Scientific's first-generation embolic protection product that was used in both the CABERNET and BEACH carotid trials. It is also the first filter-based system cleared for treatment of saphenous vein graphs in the U.S.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com/.
EndoTex Interventional Systems, Inc. is a private company located in Cupertino, CA that develops and manufactures less-invasive medical devices for use in the vascular system. Caution: Investigational Device. Limited by United States law to investigational use.
CONTACT: Paul Edwards of EndoTex Interventional Systems, Inc., +1-408-517-2800.
EndoTex Interventional Systems, Inc.CONTACT: Paul Edwards of EndoTex Interventional Systems, Inc.,+1-408-517-2800
