Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committe

Committee Meeting on January 26, 2011 from 8 a.m. to 6 p.m.

Agenda: On January 26, 2011, the committee will discuss, make recommendations and vote on information related to the PMA supplement for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular. The RX Acculink is indicated for treatment of patients at high and standard risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined as follows:1. Patients with neurological symptoms and >50 percent stenosis of the common or internal carotid artery or patients without neurological symptoms and >80 percent (high risk) or >70 percent (standard risk) stenosis of the common or internal carotid artery and 2. Patients must have a reference vessel diameter within the range of 4.0 and 9.0 mm at the target lesion.