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

October 23, 2009—Invatec (Bethlehem, PA) announced that it has received 510(k) clearance from the US Food and Drug Administration to market its Mo.Ma Ultra proximal cerebral protection device for use during carotid artery stenting procedures.

Mo.Ma Ultra is indicated as an embolic protection system to contain and remove embolic material while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and/or carotid bifurcation. The reference diameter of the external carotid artery should be between 3 and 6 mm, and the reference diameter of the common carotid artery should be between 5 and 13 mm.

According to the company, Mo.Ma Ultra establishes full-time cerebral protection and control during the carotid stenting procedure before crossing the internal carotid artery 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. Guidewires, 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, the company stated.

The company also announced completion of the ARMOUR trial, which was presented by Coprincipal Investigator L. Nelson Hopkins, MD, during the Late-Breaking Trials session of the Vascular Interventional Advances: VIVA 09 conference in Las Vegas. Results of the 262-patient ARMOUR trial support the safety and effectiveness of the Mo.Ma Ultra for patients at high surgical risk for carotid endarterectomy undergoing carotid artery stenting, Invatec stated. Details of ARMOUR and all of the late-breaking trials will be reviewed in tomorrow's special eBlast from VIVA 09 and Endovascular Today.

"Proximal embolic protection is an important advance that gives us more options in the treatment of carotid artery disease," commented Dr. Hopkins. "The Mo.Ma Ultra combines the advantages of carotid endarterectomy with the minimally invasive benefits of carotid artery stenting."