Trial Objective
To evaluate the safety and efficacy of the Carotid WALLSTENT® Endoprosthesis and the FilterWire EX®/FilterWire EZ™ Embolic Protection System in patients with carotid artery stenosis at High Risk (HR) for Carotid Endarterectomy (CEA).

Primary Endpoints
The primary endpoint of the BEACH Trial was 1-year morbidity and mortality defined as the cumulative incidence of the following:

• Non Q-wave myocardial infarction within the 24 hours following carotid stenting
• Peri-procedural (≤30 days) death, stroke, Q-wave myocardial infarction
• Late ipsilateral stroke or death due to neurologic events from 31 days up to and including twelve-month follow-up.

The primary objective of the BEACH Trial was met. The observed 1-year morbidity and mortality rate of 8.9% fell well below the predefined weighted OPC and delta of 16.6%, demonstrating that carotid artery stenting with Carotid WALLSTENNT Endoprosthesis and the FilterWire EZ Embolic Protection System is non-inferior to surgical treatment for carotid artery disease in patients who are at high risk for CEA. (See Carotid WALLSTENT Endoprosthesis Directions for Use, page 6).

Ipsilateral Stroke and Neurological Death
Further analysis of the BEACH data reveals acceptable results relating to Ipsilateral Stroke and Neurological death.

The following graph depicts the 30 day results generated in the BEACH trial for these events:

Bilateral Analysis
The Carotid WALLSTENT® Endoprosthesis is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease and meet the criteria outlined in the DFU.

The following primary endpoint results were reported in the bilateral arm of the BEACH trial (n=78):

BEACH Conclusions
Stenting with the Carotid WALLSTENT® together with the FilterWire EX®/EZ™ in a high risk surgical population, that otherwise met all other enrollment criteria, demonstrated:

• Acceptable 30 day and 1 year safety results
• Primary endpoints below OPC
• Data for bilateral arm that can be used in support of product indication