FDA Clears Invatec's Mo.Ma Ultra Proximal Cerebral EPS

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 fulltime 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 and that results of the 262-patient trial support the safety and effectiveness of the Mo.Ma Ultra for patients at high surgical risk for carotid endarterectomy undergoing carotid artery stenting. Coprincipal Investigator L. Nelson Hopkins, MD, presented the findings on October 22 at VIVA 2009: Vascular Interventional Advances annual meeting, which are summarized in the Conference Coverage section of the News in this issue of Endovascular Today.