Journal of neurosurgery
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Journal of neurosurgery · Jan 2022
ReviewCoding cerebral bypasses: a proposed nomenclature to better describe bypass constructs and revascularization techniques.
Bypass surgery has evolved into a complex surgical art with a variety of donor arteries, recipient arteries, interpositional grafts, anastomoses, and suturing techniques. Although innovation in contemporary bypasses has increased, the literal descriptions of these new bypasses have not kept pace. The existing nomenclature that joins donor and recipient arteries with a hyphen is simplistic, underinformative, and in need of improvement. This article proposes a nomenclature that systematically incorporates anatomical and technical details with alphanumeric abbreviations and is a clear, concise, and practical "code" for bypass surgery. ⋯ The authors propose a comprehensive nomenclature based on segmental anatomy and additional anastomotic details that allows bypasses to be coded simply, succinctly, and accurately. This alphanumeric shorthand allows greater precision in describing bypasses and clarifying technical details, which may improve reporting in the literature and thus help to advance the field of bypass surgery.
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Journal of neurosurgery · Jan 2022
ReviewUS FDA best practices for initiating early feasibility studies for neurological devices in the United States.
This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.