DevicePMAs@therightstef:P040012_S034 JSONTXT 11 Projects

Approval for the rx acculink carotid stent system. The device is indicated for high surgical risk and standard surgical risk patients as follows: high surgical risk -the rx acculink carotid stent system, used in conjunction with abbott vascular's accunet or emboshield family of embolic protection systems (eps), is indicated for the treatment of revascularization and meet the criteria outlined below: 1) patients with neurological symptoms and >= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram or patients without neurological symptoms and >= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; and patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. Standard surgical risk - the rx acculink carotid stent system, used in conjunction with the accunet embolic protection system (eps), is indicated for the treatment of patients at standard risk for adverse events from cartoid endarterectomy who require carotid revascularization and meet the criteria outlined below: 1) patients with neurological symptoms and >= 70% stenosis of the common or internal carotid artery by ultrasound or >= 50% stenosis of the common or internal carotid artery by angiogram or patients without neurological symptoms and >= 70% stenosis of the common or internal carotid artery by ultrasound or >= 60% stenosis of the common or internal carotid artery by angiogram; and patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.