Neurosurgery
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The US Food and Drug Administration allows a previously unapproved device to be used clinically to collect safety and effectiveness data under their Investigational Device Exemption (IDE) category. The process usually falls under 3 different trial categories: noninferiority, equivalency, and superiority. To confidently inform our patients, understanding the basic concepts of these trials is paramount. The purpose of this manuscript was to provide a comprehensive review of these topics using recently published IDE trials and economic analyses of cervical total disc replacement as illustrative examples. ⋯ While large Food and Drug Administration IDE studies are often besieged by complex statistical considerations and calculations, it is fundamentally important that clinicians understand at least the terminology and basic concepts on a practical level.
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Bifurcation middle cerebral artery (MCA) aneurysms with wide neck are amenable to endovascular coiling with pCONus stent, a recent device dedicated to wide-neck bifurcation intracranial aneurysms. ⋯ pCONus stent allows a safe coiling of wide-neck MCA aneurysms usually considered as surgical with a low recanalization rate for those adequately occluded at 3 to 6 months. Angiographic results improve over time due to progressive aneurysm thrombosis in around 50% of cases.
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Although patients with brain metastasis are treated with primary stereotactic radiosurgery (SRS), the use of salvage therapies and their consequence remains understudied. ⋯ In selected patients, performing ≥3 SRS courses controls intracranial disease. Patients may need salvage SRS for distant intracranial relapse, but focal retreatments are associated with modest toxicity, do not appear to negatively affect a patient's performance status, and help preserve quality of life.