Positive Data Presented for Invatec's Mo.Ma CAS Protection Device

May 6, 2010—At the Society for Cardiovascular Angiography and Interventions (SCAI) 33rd annual scientific sessions, Robert M. Bersin, MD, presented findings from the ARMOUR study of the Mo.Ma protection device (Invatec, Inc., Bethlehem, PA; recently acquired by Medtronic, Inc., Minneapolis, MN) that demonstrate the safety and effectiveness of the device. The ARMOUR study showed that when the Mo.Ma protection device was placed upstream of a cholesterol blockage in the carotid arteries, the 1-month risk of myocardial infarction, stroke, or death was approximately 75% lower than would be typical with a downstream filter. 

The transcatheter Mo.Ma protection device is composed of two balloons that are positioned forward of the blockage: one in the main carotid artery, and one in the external carotid artery. Inflation of the balloons temporarily stops blood flow to the internal carotid artery, where the blockage is located. After angioplasty and stenting of the lesion, a syringe is used to suction out any loose debris repeating until no more particles are visible.

To evaluate the safety and effectiveness of the Mo.Ma protection device, investigators at 25 medical centers in the United States and Europe recruited 225 high-surgical-risk patients. The procedure was reported to be successful without major adverse cardiovascular or cerebrovascular events (MACCE), including myocardial infarction, stroke, or death, in 93% of patients. Within 30 days of stenting, the combined MACCE rate was 2.7%, whereas a 13% MACCE rate was predicted on the basis of experience with filter protection devices. The major stroke rate was < 1%. In addition, patients who were experiencing stroke-like symptoms at the time of the procedure had no higher MACCE rate than the overall group, whereas a doubling of the MACCE rate is typical in symptomatic patients treated with filter protection devices, stated Dr. Bersin. Among patients older than 75 years, the MACCE rate was 2.3%. 

“The Mo.Ma device protects the brain before we ever touch the lesion,” commented Dr. Bersin. “This is one of the best results ever observed for carotid stenting. The idea that carotid stenting is not safe in the elderly no longer applies."