A device using two angioplasty balloons to temporarily block blood flow to the brain while placing carotid stents in high surgical-risk patients offers a safe and effective way to prevent stroke from occurring during treatment, according to research released at the Society of Interventional Radiology’s 35th Annual Scientific Meeting in Tampa, Fla. last month.
“The Mo.Ma device, 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,” said Barry T. Katzen, MD, FSIR, medical director of Baptist Cardiac and Vascular Institute in Miami. “The Mo.Ma device provides an important alternative to surgery for stroke prevention.”
The device establishes full-time cerebral protection during the carotid stenting procedure prior to crossing the internal carotid artery lesion. Small balloons are inflated in both the external carotid artery and the common carotid artery to suspend blood flow during the stenting procedure. 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.
Katzen presented results from the ARMOUR trial study involving 262 patients enrolled at 20 investigational sites in the United States and five in the European Union between September 2007 and February 2009. At 30 days, researchers found that the major adverse cardiac and cerebrovascular event rate (MACCE) of stroke, death and heart attack was 2.7% with the Mo.Ma device, which is less than the 13% MACCE rate derived from previous carotid stenting trials. The major stroke rate through 30 days in the study was less than 1%.
Katzen noted that other so-called debris catcher and other balloon occlusion devices are currently available, but the Mo.Ma device refines carotid stenting treatment. Such ischemic strokes account for 70% to 80% of strokes. Strokes kill approximately
In the ARMOUR trial, patients with carotid artery disease and were not suitable candidates for surgery were considered for carotid artery stenting accompanied by the use of the Mo.Ma device. Patients who met inclusion/exclusion criteria were enrolled in the trial, which was a 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 80 or older. Nearly 67% were men. Patients were assessed at 30 days to measure the continued success and any ill effects of the procedure.
Following FDA review, Invatec Inc received clearance to market the Mo.Ma device for use during carotid artery stenting in the United States.
— Source: Society of Interventional Radiology