Boston Scientific and Endotex Interventional Systems, Inc. Announce Completion of Enrollment in Carotid Stenting Trial
Natick, MA, March 25, 2004 - Boston Scientific Corporation (NYSE: BSX) and EndoTex Interventional Systems, Inc. announced today the completion of enrollment in a carotid artery stenting clinical trial to evaluate the benefits of stenting in conjunction with embolic protection to treat carotid artery disease. The clinical trial, known as CABERNET, uses the EndoTex NexStent™ Carotid Stent (NexStent) in conjunction with the Boston Scientific FilterWire EZ™ Embolic Protection System (FilterWire EZ) to treat patients who are at high risk for a carotid endarterectomy (CEA). Both NexStent and FilterWire EZ are limited by United States law to investigational use. FilterWire EZ has been granted CE Mark and is commercially available in Europe and other international markets.
CABERNET is a single-arm, prospective, non-randomized trial enrolling 450 patients at high-risk for CEA at 15 sites across the United States.
The carotid arteries, located on either side of the neck, are the main conduit for blood flow to the brain. Plaque formation in these arteries can lead to carotid occlusive disease, putting these patients at risk for stroke. Stroke is the nation's third leading cause of death, killing nearly 160,000 Americans every year.
The EndoTex NexStent Carotid Stent consists of a laser-cut, rolled sheet of nitinol. The rolled sheet design enables NexStent to adapt to multiple diameters and to tapered or non-tapered configurations, providing customized treatment of stenotic lesions in the carotid arteries. The Boston Scientific FilterWire EZ Embolic Protection System is a low-profile filter mounted on a rapid exchange deployment system designed to capture embolic debris that is released during a procedure to prevent it from traveling to the brain, where it could cause a stroke.
"We are pleased to complete the enrollment phase of this pivotal trial," said Nick Hopkins, M.D., Professor & Chairman of Neurosurgery of Department of Neurosurgery, State University of New York in Buffalo, NY, the Principal Investigator of the CABERNET trial. "This trial, which focused on patients at high risk for surgery, contributes to the mounting evidence suggesting that carotid stenting may be shown to be a safe and effective less-invasive alternative for patients with carotid occlusive disease who are at increased risk of stroke."
"The CABERNET Trial enlisted a stellar group of investigators to evaluate an exciting combination of two technologies-the EndoTex NexStent Carotid Stent and the Boston Scientific FilterWire EZ Embolic Protection System," said Mark Wholey, M.D., Chairman of the Pittsburgh Vascular Institute at the University of Pittsburgh Medical Center - Shadyside in Pittsburgh, a CABERNET Investigator and Scientific Advisory Board Member."This combined technology may prove to be an innovative and effective treatment option for high-risk patients with carotid artery disease."
"We are very pleased to complete this pivotal study with a prestigious group of clinical investigators, and with Boston Scientific, a leader in interventional therapies," said Joe Tartaglia, CEO and President of EndoTex. "We are encouraged and optimistic that this technology will provide positive future outcomes for high-risk patients." "The preliminary feedback from the CABERNET trial is very promising, and we are delighted about our ongoing collaboration with EndoTex," said Matthew Jenusaitis, President of Peripheral Interventions for Boston Scientific Corporation. "We are looking forward to the results from the follow-up phase."
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: 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.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process, commercialization of new technologies and other factors described in the Company's filings with the Securities and Exchange Commission.
CEO and President
Boston Scientific Corporation