Cerebral protection device used in combination with minimally invasive FDA-approved carotid stents in high surgical risk patients advances stroke care and shows safety, effectiveness outcomes.
TAMPA, FL—An advancement in interventional radiology—the use of a cerebral protection device in combination with FDA-approved carotid stents in high surgical risk patients—provides a minimally invasive, safe, and effective way to prevent stroke from occurring during treatment to clear blocked carotid arteries, according to research presented at the 35th Annual Scientific Meeting of the Society of Interventional Radiology.
“Interventional radiologists are at the forefront in advancing stroke care,” commented Barry T. Katzen, MD, Clinical Professor of Radiology at the University of Miami School of Medicine and Medical Director of the Baptist Cardiac and Vascular Institute in Miami. “Using a new FDA-approved cerebral protection device during carotid artery stenting effectively reduces and captures particles released during the stenting procedure in order to prevent this debris from traveling to the brain, where it has the potential to cause a stroke.
“The Mo.Ma device,” Dr. Katzen continued, “which uses balloons that are inflated and act like endovascular surgical clamps to protect the brain during the procedure, provides a treatment option for patients who may not be healthy enough to undergo surgery—for example, those with severe heart or lung disease or those who have had neck operations or radiation for neck tumors. The Mo.Ma device provides an important alternative to surgery for stroke prevention.”
A total of 262 patients were enrolled at 25 investigational sites in the US (20) and the European Union (5) between September 2007 and February 2009 in the ARMOUR [Proximal Protection with the Mo.Ma Device During Carotid Stenting] trial. At 30 days, the major adverse cardiac and cerebrovascular event rate (MACCE) of stroke, death, and heart attack was 2.7%, with the major stroke rate through 30 days at less than 1%—compared with a 13% MACCE rate typically derived from previous carotid stenting trials. A low MACCE rate demonstrates the safety and effectiveness of the device in clinical use, noted Dr. Katzen.
“This device and interventional radiology treatment are added tools to improve stroke prevention,” he said. Dr. Katzen added that although there are “debris catcher” and other balloon occlusion devices currently available, the Mo.Ma device refines carotid stenting treatment.
“The data collected in the ARMOUR trial have led to FDA clearance, thus allowing broader physician access to the Mo.Ma proximal cerebral protection device in the treatment of patients with carotid artery disease,” said Dr. Katzen.
Patients with carotid artery disease who were not suitable candidates for carotid artery surgery were considered for carotid artery stenting accompanied by the use of the Mo.Ma device. Subjects who provided written informed consent and met inclusion/exclusion criteria were enrolled in the ARMOUR trial, a pivotal, prospective, multicenter, nonrandomized trial to evaluate the safety and effectiveness of the device.
The average age of the patients was 75, and nearly 29% were octogenarians and about 67% were men. Patients were assessed at 30 days to measure the continued success of the procedure and any ill effects that may have occurred. Following FDA review, Invatec Inc (Roncadelle, Italy) received clearance to market the Mo.Ma device for use during carotid artery stenting in the US.
The Mo.Ma device establishes full-time cerebral protection during carotid stenting prior to crossing the internal carotid artery lesion. It comprises two small balloons that are inflated in the external carotid artery and the common carotid artery to suspend blood flow during stenting. The balloons act like endovascular surgical clamps, protecting the brain during the procedure. The suspended blood is then aspirated along with any particles to complete the procedure safely.