Invatec has announced that it has received 510(k) clearance from the FDA to market its Mo.Ma Ultra Proximal Cerebral Protection Device for use during carotid artery stenting. The device reduces and captures debris released during the stenting procedure to prevent it from traveling to the brain, where it has the potential to cause a stroke.
According to Invatec, Mo.Ma Ultra establishes full-time cerebral protection and control during the carotid stenting procedure prior to crossing the internal carotid artery lesion, thereby preventing distal embolisation. Small balloons on the tip and proximal shaft are inflated in the external carotid artery and the common carotid artery to suspend blood flow during the stenting process. These balloons act like endovascular surgical clamps, protecting the brain during the procedure. However the easy-to-use percutaneous Mo.Ma Ultra requires no surgery. Guide wires, stents and balloon catheters are used in this protected environment to treat the target lesion through the Mo.Ma Ultra Device, which provides stability, control and access to the internal carotid artery like a guiding catheter or sheath. The suspended blood is then aspirated along with any embolic debris to complete the procedure safely.
L Nelson Hopkins, State University of New York in Buffalo, USA, and co-principal investigator of the ARMOUR trial stated, “Proximal embolic protection is an important advance that gives us more options in the treatment of carotid artery disease. The Mo.Ma Ultra combines the advantages of carotid endarterectomy with the minimally invasive benefits of carotid artery stenting.”
Hopkins reported results of the pivotal, multi-centre, non-randomised ARMOUR trial at VIVA 2009 in Las Vegas during the conference’s late-breaking trials session on 22 October.
Results of the 262-patient ARMOUR trial support the safety and effectiveness of Mo.Ma Ultra for patients at high surgical risk for carotid endarterectomy undergoing stenting. Mo.Ma Ultra’s full-time protection and control contributed to a low 30-day stroke rate of 2.3% and major adverse cardiac and cerebrovascular events (stroke, death and myocardial infarction) rate of 2.7% in the primary endpoint 220-patient population set. “The primary endpoint results of the ARMOUR trial are impressive and support the benefits of proximal protection. We look forward to the availability of Mo.Ma Ultra in the US market,” commented Gary Ansel, Riverside Methodist Hospital in Columbus, and co-principal investigator of the ARMOUR trial.
Mo.Ma Ultra Proximal Cerebral Protection Device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and/or the carotid bifurcation. The reference diameter of the external carotid artery should be between 3–6mm and the reference diameter of the common carotid artery should be between 5–13mm.