Preliminary results from the Carotid Artery Revascularisation Using the Boston Scientific EPI FilterWire EX/EZ and the EndoTex NexStent Trial (CABERNET) have been presented at the EuroPCR Conference in Paris, France.
The CABERNET trial was designed to evaluate the safety and efficacy of carotid artery stenting as a minimally invasive alternative for treating carotid artery disease and reducing the risk of stroke in patients either ineligible or at high risk for surgery. The trial was a prospective, non-randomised, multi-center, single-arm clinical study. It was performed to demonstrate the safety and efficacy of the EndoTex NexStent Carotid Stent System, developed by EndoTex Interventional Systems, Inc (EndoTex), and Boston Scientific's FilterWire EX/EZ Embolic Protection Systems when used to treat high-risk, surgical and non-surgical, symptomatic (> or = 50% stenosis) and asymptomatic (> or = 80% stenosis) subjects with disease in the internal carotid artery. A total of 454 patients were enrolled at 19 clinical sites (15 in the US and four international sites).
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 rolled Nitinol sheet (stent) that is placed in a 5F delivery system. This design allows the stent to accommodate a tapered or non-tapered configuration, as well as adapt or self size to arterial diameters between 4mm and 9mm.
The results show that the composite major adverse event (MAE) rate at one-year (defined as any death, stroke or MI < or = 30 days post-procedure plus any ipsilateral stroke including any death as a result of an ipsilateral stroke from 31-365 days) was 4.5% (death 0.5%, stroke 4.0%, MI 0.2%).
Principal Investigator Dr L Nelson Hopkins, Professor & Chairman of Neurosurgery at the University at Buffalo, State University of New York, said, "The exceptional results from the CABERNET Trial clearly exceeded our expectations. These results compare very favourably with other similar US high risk carotid artery stenting trials and appear competitive with the major carotid endarterectomy trials."
"The complexities of carotid artery anatomy and lesion morphologies require tailored solutions," said Dr Alberto Cremonesi, Director of the Interventional Cardio-Angiology Unit at the Villa Maria Cecilia Hospital in Cotignola, Italy. "The NexStent, with its dynamic tapering design and closed cell structure, offers a combination of key attributes which are designed for use in soft heterogeneous plaques and focal concentric and eccentric lesions."
EndoTex recently received CE Mark approval for the NexStent Carotid Stent and Monorail Delivery System. The company has initiated the launch of the product within countries in the European Union, in conjunction with its distribution partner, Boston Scientific.
"We are very pleased that the CABERNET one-year data which strongly supports our belief that carotid stenting, especially with the NexStent system is a viable alternative to carotid artery surgery in a high risk patient population," said Joseph Tartaglia, President and CEO of EndoTex Interventional Systems.
"The one-year CABERNET data supports the NexStent as one of the premier technologies for the treatment of carotid artery disease. The single rolled sheet design of the NexStent system represents a technological breakthrough yielding the first sub 5F carotid stent delivery system commercially available. Our strong initial sales in Europe demonstrate that the market agrees with our internal assessment of the strength of this technology," said Matthew Jenusaitis, President of Peripheral Interventions for Boston Scientific.
EndoTex expects to file its US PMA submission with the FDA for the NexStent system in the near future with an anticipated clearance in the beginning of 2006. The EndoTex NexStent is currently not for sale in the US.
|
