FDA Clears Invatec's Mo.Ma Ultra Proximal Cerebral Protection Device


October 26, 2009

October 27, 2009 – Invatec today said it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Mo.Ma Ultra Proximal Cerebral Protection Device for use during carotid artery stenting (CAS). The device effectively 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.

Carotid stenting, a procedure that inserts wire mesh tubes to prop open the arteries and improve blood flow, is a common treatment for carotid artery disease, a condition caused by buildup of fatty substances and plaque. When the carotid arteries are obstructed, patients are at an increased risk for stroke, the third leading cause of death in the U.S. Mo.Ma Ultra is a proximal protection device, which establishes full-time cerebral protection and control during the carotid stenting procedure prior to crossing the internal carotid artery (ICA) lesion, thereby preventing distal embolization. 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, M.D., of State University of New York in Buffalo and coprincipal 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.”

ARMOUR Clinical Trial Results

Dr. Hopkins reported results of the pivotal, multicenter, nonrandomized ARMOUR trial at VIVA 2009 in Las Vegas during the conference’s late breaking trials session Oct. 22.

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 CAS. Mo.Ma Ultra’s full-time protection and control contributed to a low 30-day stroke rate of 2.3 percent and MACCE (stroke, death and myocardial infarction) rate of 2.7 percent 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 U.S. market,” commented Gary Ansel, M.D., of Riverside Methodist Hospital in Columbus, Ohio and coprincipal 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 3-6 mm and the reference diameter of the common carotid artery should be between 5-13 mm.

For more information: www.invatec.com