The US FDA 510(k) clearance has been given to the SpideRX Embolic Protection Device of ev3 Inc. for use in carotid artery stenting applications. ev3 is prepared to release the product immediately for commercial sale.
FDA clearance was supported by a 160-patient high-risk carotid stent registry as part of ev3's CREATE Carotid Registry (which also included a 419-patient arm studying the Protege GPS Self-Expanding Stent and the SPIDER Over-the-Wire Device). This arm of the study was designed to evaluate the SpideRX rapid exchange Embolic Protection Device for use with the Guidant RX ACCULINK Carotid Stent System. The primary endpoint was defined as 30-day major adverse cerebrovascular and cardiovascular events (MACCE) including myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA or death. MACCE at 30 days for the SpideRX arm occurred in 5.6 per cent of patients.
Dr. Gary Ansel, Riverside Hospital, Columbus, Ohio, national Co-Principal Investigator for the CREATE Trial stated, "The CREATE Trial data confirms the success and safety of the SpideRX Device for use in carotid stenting of patients at increased surgical risk."
Carotid arteries, located on either side of the neck, are the main conduits for blood flow to the brain. When narrowing occurs, patients are at risk for stroke. Stroke is the nation's third leading cause of death, affecting nearly 700,000 Americans each year. Embolic protection devices are small filters placed beyond a blockage in the carotid arteries to collect debris released during stent placement to prevent a stroke or other neurological event.
The SpideRX Device features a unique nitinol filter to capture embolic debris. The device is designed to provide efficient delivery, capture and recovery while allowing interventionalists to use their interventional wire of choice. Improvements over the Spider Over-the-Wire system include a complete rapid exchange system, 6 Fr. guide catheter compatibility and a unique dual-end delivery/recovery catheter with a pre-loaded capture wire.
Dr. Ansel also commented, "The SpideRX Device is unique in that it allows physicians to utilize their own wire system of choice, leading to consistent success in placing the embolic protection device during carotid interventions."