EndoTex Interventional Systems Announces European Approval of Novel Carotid Stent Delivery System
Innovative Self-Expanding Stent Delivery System Designed Specifically for the Treatment of Patients with Carotid Artery Disease
CUPERTINO, Calif., April 13 PRNewswire - EndoTex Interventional Systems, Inc. (EndoTex) today announced Conformite Europeenne (CE) Mark approval of its NexStent(TM) Carotid Stent and Monorail(TM) Delivery System. The company's NexStent Carotid Stent System provides a minimally invasive approach for treating carotid artery disease, avoiding the more invasive surgical procedure called carotid endarterectomy (CEA).
"The results from CABERNET suggest that CAS in this high-risk patient subset appears competitive with the major CEA trials. This Innovative, sleek design delivered impressive results; a no nonsense, one size fits all stent," said Subbarao Myla, M.D., Co-Principal Investigator of the CABERNET trial and Medical Director, CV Research & Vascular Intervention at Hoag Memorial Hospital.
"We at EndoTex are very pleased that the NexStent(TM) Carotid Stent and Monorail(TM) Delivery System has received the CE Mark. EndoTex is committed to providing physicians with an innovative, effective and easy to use technology for treating carotid artery disease," said Joseph Tartaglia, CEO and President of EndoTex Interventional Systems. "We are looking forward to the market release of the NexStent in Europe in the near future and distribution through our strategic partner, Boston Scientific Corporation."
"This is another step forward in our collaborative relationship with EndoTex," said Matthew Jenusaitis, President of Peripheral Interventions for Boston Scientific. "We are confident that the NexStent technology will be one of the cornerstones of our carotid artery solutions portfolio. The result of the CE mark is a great product that gets in the hands of physicians faster."
The NexStent system is a novel self-expanding stent design that is specifically designed to adapt and conform to the unique anatomy of the carotid vasculature. This design is composed of a 30mm length coiled sheet, Nitinol stent in a 5F delivery system that allows the stent to not only take on a tapered or non-tapered configuration, but also allows the stent to self size to arterial diameters between 4 and 9mm.
In May 2003 Boston Scientific Corporation (NYSE: BSX - News) made a second equity investment in -- and extended its exclusive option to acquire -- EndoTex Interventional Systems, Inc. In addition, Boston Scientific has agreed to acquire EndoTex upon the achievement of certain regulatory milestones. As part of the arrangement, EndoTex extended Boston Scientific's term as its exclusive distributor. Boston Scientific will serve as the primary distributor for EndoTex in international markets. The companies intend to continue to collaborate in the CABERNET clinical trial of the EndoTex NexStent carotid stent and Boston Scientific's FilterWire embolic protection device.
About Carotid Artery Disease and Stroke
Stroke is the third leading cause of death in the United States and the number one cause of disability in adults, according to the American Heart Association. Approximately 25 percent of strokes are caused by carotid artery disease. Clogged carotid arteries can cause ischemic stroke, the most common type. More than 700,000 Americans will have new (500,000) or recurrent (200,000) strokes each year, and 280,000 will die from these strokes.
About Boston Scientific Corporation
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.
About EndoTex Interventional Systems
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. For more information, please visit: www.endotex.com.