Neurovascular Embolization Coils and the Potential for ... | 合法醫療器材資訊網

2018年3月12日—Asaneurysmstreatedwithcoilsmayhaveresidualfillingormayrecur,putting...ofsafeuseofthedevicewhenscannedwithinanMRenvironment....conditionsprovidedintheMRIconditionallabelingofthecoilsystem(e.g., ...

Dear Health Care Provider,

The FDA is providing information about the potential for increased image artifact associated with Magnetic Resonance Angiography (MRA) imaging for patient follow-up of certain post neurovascular embolization coil procedures.

Neurovascular embolization coils are used in the treatment of brain aneurysms and other vascular abnormalities. These coils are prescription devices implanted by a physician into the aneurysm sac to occlude blood flow and promote thrombosis. As aneurysms treated with coils may have residual filling or may recur, putting the patient at risk for late hemorrhage, follow-up imaging is performed when necessary post procedure. Digital subtraction angiography (DSA) has traditionally been the method used for imaging aneurysms after coiling. However, with advances in MRA image quality and accessibility, many ...