CABERNET Demonstrates Favorable Outcomes in High-Risk Patients

EndoTex Interventional Systems has announced the favorable results of the CABERNET trial, 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 CABERNET (Carotid Artery Revascularization Using the Boston Scientific EPI FilterWire EX/EZ and the EndoTex NexStent) trial was a prospective, nonrandomized, multicenter, single-arm clinical study with a total of 454 patients enrolled at 19 clinical sites in the U.S. and abroad. One-year CABERNET data show the composite MAE rate -- defined as any death, stroke or myocardial infarction greater than or equal to 30 days postprocedure plus any ipsilateral stroke, including any death as a result of an ipsilateral stroke, from 31 to 365 days -- was 4.5 percent.

EndoTex recently received CE mark approval of its NexStent Carotid Stent and Monorail Delivery System and has initiated the launch of the product within countries in the European Union in conjunction with its distribution partner Boston Scientific. The company expects to file its U.S. premarket approval submission with the FDA for the NexStent system in the near future with an anticipated clearance in the beginning of 2006.