The SPIDER Embolic Protection Device performance evaluation in the carotid artery during percutaneous transluminal angioplasty and or stenting.

Recently completed studies have compared carotid endarterectomy with carotid artery stenting, a nonsurgical method of improving blood flow in the carotid arteries. Embolic protection devices can prevent particles dislodged during carotid artery stenting from causing stroke or death. An ev3 Inc.-sponsored trial (PROTECT) evaluated the performance requirements of the SPIDER Embolic Protection Device in the carotid artery for CE Marking. Patients who were candidates for percutaneous transluminal angioplasty (PTA) and or stenting were enrolled. Performance was assessed by determining the incidence of major adverse neurological events (MANE) through 30 days post-procedure in 74 patients, along with the successful placement and recovery rates of the filter. MANE was defined as stroke or death. There were a total of 5 MANE events reported in 5 patients, 1 major stroke and 4 minor strokes. There were no deaths. The total MANE event rate was 6.8% (5 of 73). The overall SAE rate was 8.2% (6 of 73). An SAE was defined as an event that resulted in the hospitalization or prolongation of hospitalization due to potential disability, or due to danger of life that resulted in an intervention or that was terminal. Technical success of the SPIDER device was defined as placement of the filter at the distal edge of the lesion in the carotid artery, placement of the recovery catheter and successful retrieval of the filter with the recovery catheter. An inability to place or retrieve the filter was concluded to be a system failure. The SPIDER device was successfully placed in the carotid artery and retrieved with an overall successful placement rate of 88.1% (74 of 84), and a retrieval rate of 98.6% (73 of 74). In conclusion, the PROTECT Trial demonstrated that the performance of the SPIDER device in the carotid artery complied with the relevant Product Directives for CE Marking. The incidence of MANE was low and comparable to what has been reported in recently published literature.