Use of the Mo.Ma proximal cerebral protection device (Invatec) used with FDA-approved carotid stents in high-risk patients are 98 percent effective and proved to decrease risk of stroke, according to results of the ARMOUR trial presented by Barry T. Katzen, MD, at the 35th annual Society of Interventional Radiology Scientific Meeting March 15.
"Interventional radiologists are at the forefront in advancing stroke care. 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 travelling to the brain where it has the potential to cause a stroke," said Katzen, of the Baptist Cardiac & Vascular Institute in Miami.
According to Katzen, the Mo.Ma device acts as an alternate treatment for patients who are too unhealthy to undergo surgery—those with heart or lung disease or who have underwent neck operations or radiation for neck tumors.
The nonrandomized trial enrolled 262 patients with carotid artery disease (CAD) at 25 investigation sites throughout the U.S. and Europe between September 2007 and February 2009 to evaluate the safety and effectiveness of the Mo.Ma device.
Of the 262 patients, 67 percent were men, none were suitable candidates for carotid artery surgery and all had an average age of 75.
During the trial, researchers evaluated major adverse cardiac and cerebrovascular event rates at 30 days post-procedure. The results showed that the rates of stroke, heart attack and death were 2.7 percent, while stroke rates were reported as being less than 1 percent.
In comparison, the usual rates of stroke derived from previous clinical trials were reported at 13 percent, according to Katzen.
Additionally, the researchers found that the complication rate at the access site was 3.1 percent.
"This device and interventional radiology treatment are added tools to improve stroke prevention," he noted. “While there are debris catcher and other balloon occlusion devices currently available, the Mo.Ma device refines carotid stenting treatment.”
The Mo.Ma device has two small balloons, which are inflated in the external and common carotid artery to suspend blood flow during a stenting procedure. The balloons act as endovascular surgical clamps to protect a patient’s brain during the procedure while blood is then aspirated to complete the procedure, according to Katzen.
The positive results of the ARMOUR trial has led to FDA approval of the device, according to Katzen.