Less than two months after FDA approval of Boston Scientific's (Natick, Massachusetts) Carotid Wallstent Monorail Endoprosthesis for patients with carotid artery disease who are at high risk for surgery, the first patient has been enrolled in a 1,000-patient surveillance registry.
"The CABANA (Carotid Stenting Boston Scientific Surveillance Program) registry is a condition of FDA approval and it's intended to gather early outcomes data in a real world setting," Scott Warren, group marketing manager, carotid solutions at Boston Scientific, told Medical Device Daily.
Wallstent has the smallest free-cell area with a closed-cell stent design, according to the company. It has an ability to be re-constrained, allowing physicians to stop, re-constrain and re-deploy when necessary to get better placement. Warren said it is the only carotid artery stent system approved in the U.S. with an indication for bilateral carotid artery disease, meaning blockages in the carotid arteries on both sides of the neck.
Carotid artery disease occurs when fatty plaque builds up inside the main vessels that carry blood from the heart to the brain. The plaque builds up, hardens and narrows, making a person susceptible to stroke.
The stent is approved to be used along with the company's FilterWire EZ Embolic Protection System.
The CABANA Study is a multi-center, U.S. surveillance registry designed to enroll a minimum of 1,000 patients at up to 150 sites. Researchers are focused on compiling early clinical outcomes data for the Wallstent with the FilterWire in routine clinical practice.
The FDA approved the Wallstent in October (MDD, Oct. 27, 2008). The FilterWire EZ Embolic Protection System received FDA clearance for use in carotid artery stenting procedures on Dec. 14, 2006.
"The Carotid Wallstent was evaluated as a complete system along with the Protection System, so it's approved together as a system," Warren said.
The FilterWire System captures plaque debris that may be released during a procedure, preventing it from traveling to the brain where it could cause a stroke.
The first patient was enrolled in the CABANA Study by Rajesh Dave, MD, chairman, of endovascular medicine at Pinnacle Health Heart and Vascular Institute, Harrisburg Hospital (Harrisburg, Pennsylvania).
Warren said that the system is the only one indicated in the U.S. for the treatment of certain patients at high risk for surgery with either ipsilateral or bilateral carotid artery disease (blockages in carotid arteries on one or both sides of the neck).
"Carotid artery stents are for all patients at risk for enterectomy, a surgical approach during which the artery is opened and plaque is scraped away," he said. "There are some patients at higher risk due to anatomical or co-morbid risk factors. That population was studied in BEACH trial."
The BEACH Trial was a prospective, non-randomized, single-arm clinical trial with 480 patients, which demonstrated the safety and efficacy of the Wallstent and FilterWire system. The primary endpoint in the BEACH trial was one-year morbidity and mortality.
The one-year morbidity and mortality rate reported from the BEACH trial was 8.9%; the ipsilateral stroke rate (a stroke occurring on the treated side) was 3.3% and the major ischemic stroke rate was 1.1% at 30 days.