1,123 research outputs found

    Application of Investigational Device Exemptions regulations to endograft modification

    Get PDF
    For patients with complex aortic aneurysms that cannot be treated effectively with currently approved endografts, physicians have made fenestrations in marketed devices and constructed branched grafts by creatively implanting available endograft components. For the most part, these procedures are being done outside of clinical studies by individual physicians. Although these novel approaches may be useful in the treatment of individual patients, the current ad hoc use of physician-created fenestrated and branched devices may not result in the unbiased capture and reporting of data regarding short- and longer-term outcomes. As a result, unsubstantiated conclusions regarding the safety and effectiveness of these procedures may be drawn. Well-designed and executed clinical studies are necessary to adequately assess the benefits and risks of these techniques. Because these interventions involve the use of significant risk devices, these studies need to be conducted under United States Food and Drug Administration-approved Investigational Device Exemptions (IDE) applications. Although this regulatory process adds complexity to the application of these creative techniques, the IDE regulations assure that patient protection measures are followed and data are captured to assess safety and effectiveness. This approach creates opportunities to advance the development of innovative, beneficial devices and procedures to treat complex aortic aneurysms

    Constructing communities for learning in nursing

    Get PDF

    Integrated Solar Array and Reflectarray Antenna for High Bandwidth Cubesats

    Get PDF
    The Integrated Solar Array and Reflectarray Antenna (ISARA) mission will demonstrate a reflectarray antenna that increases downlink data rates for Cube- Sats from the existing baseline rate of 9.6 kilobits per second (kbps) to more than 100 megabits per second (Mbps). The ISARA spacecraft is slated for launch no earlier than Dec. 1, 2015
    • …
    corecore