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Ann Arbor, MI, United States

Kalemkerian G.P.,University of Michigan | Kalemkerian G.P.,500 East Medical Center Drive | Gadgeel S.M.,Barbara Ann Karmanos Cancer Institute
JNCCN Journal of the National Comprehensive Cancer Network | Year: 2013

For many years, small cell lung cancer (SCLC) has been staged using the Veterans Affairs classification system, which includes only 2 stages: limited (primary tumor and regional lymph nodes within a tolerable radiation field) and extensive (anything beyond limited stage). The TNM staging system used for non-small cell lung cancer is also prognostic for SCLC and should be integrated into the classification scheme for patients with SCLC. The staging workup for SCLC has traditionally included contrast-enhanced CT scans of the chest and abdomen, bone scan, and MRI or CT scan of the brain. Recent data suggest that PET can improve both staging accuracy and treatment planning in patients with SCLC, although further prospective studies are needed to fully define its role. Copyright © 2013, JNCCN-Journal of the National Comprehensive Cancer Network. Source


Evans A.T.,University of Michigan | Park J.M.,University of Michigan | Chiravuri S.,500 East Medical Center Drive | Gianchandani Y.B.,University of Michigan
Biomedical Microdevices | Year: 2010

This paper describes an actively-controlled architecture for drug delivery systems that offers high performance and volume efficiency through the use of micromachined components. The system uses a controlled valve to regulate dosing by throttling flow from a mechanically pressurized reservoir, thereby eliminating the need for a pump. To this end, the valve is fabricated from a glass wafer and silicon-oninsulator wafer for sensor integration. The valve draws a maximum power of 1.68 μW (averaged over time); with the existing packaging scheme, it has a volume of 2.475 cm3. The reservoirs are assembled by compressing polyethylene terephthalate polymer balloons with metal springs. The metal springs are fabricated from Elgiloy® using photochemical etching. The springs pressurize the contents of 37 mL chambers up to 15 kPa. The system is integrated with batteries and a control circuit board within a 113 cm3 metal casing. This system has been evaluated in different control modes to mimic clinical applications. Bolus deliveries of 1.5 mL have been regulated as well as continuous flows of 0.15 mL/day with accuracies of 3.22%. The results suggest that this device can be used in an implant to regulateintrathecal drug delivery. © 2009. Springer Science + Business Media, LLC. Source


Levi B.,University of Michigan | Lisiecki J.,University of Michigan | Rubin P.,University of Michigan | D'Amico R.A.,University of Michigan | And 3 more authors.
Plastic and Reconstructive Surgery | Year: 2014

The U.S. Food and Drug Administration is the government agency responsible for oversight of the safety and efficacy of pharmaceuticals and devices, including biologics and devices that combine biologics with other materials. Within the U.S. Food and Drug Administration, the Center for Biologics Evaluation and Research is specifically responsible for the evaluation and approval of biological products. This department of the U.S. Food and Drug Administration has a series of mechanisms in place to aid researchers in the process of developing new biologics. This article outlines the study phases involved in developing new biologics and how the Center for Biologics Evaluation and Research and investigators can work together to facilitate this process. It also discusses issues specific to biologics that have been encountered in the past and that investigators should consider when developing and obtaining approval for new biologics. The equivalent center within the U.S. Food and Drug Administration for approving medical devices is the Center for Devices and Radiological Health. The equivalent process of development and approval of medical devices is similarly discussed. Finally, essential contacts for investigators within the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health are provided. Copyright © 2014 by the American Society of Plastic Surgeons. Source


Mitsak A.G.,101 Beal Avenue | Dunn A.M.,101 Beal Avenue | Hollister S.J.,101 Beal Avenue | Hollister S.J.,Gg Brown Laboratory | Hollister S.J.,500 East Medical Center Drive
Journal of the Mechanical Behavior of Biomedical Materials | Year: 2012

Scaffold tissue engineering strategies for repairing and replacing soft tissue aim to improve reconstructive and corrective surgical techniques whose limitations include suboptimal mechanical properties, fibrous capsule formation and volume loss due to graft resorption. An effective tissue engineering strategy requires a scaffolding material with low elastic modulus that behaves similarly to soft tissue, which has been characterized as a nonlinear elastic material. The material must also have the ability to be manufactured into specifically designed architectures. Poly(glycerol sebacate) (PGS) is a thermoset elastomer that meets these criteria. We hypothesize that the mechanical properties of PGS can be modulated through curing condition and architecture to produce materials with a range of stiffnesses. To evaluate this hypothesis, we manufactured PGS constructs cured under various conditions and having one of two architectures (solid or porous). Specimens were then tensile tested according to ASTM standards and the data were modeled using a nonlinear elastic Neo-Hookean model. Architecture and testing conditions, including elongation rate and wet versus dry conditions, affected the mechanical properties. Increasing curing time and temperature led to increased tangent modulus and decreased maximum strain for solid constructs. Porous constructs had lower nonlinear elastic properties, as did constructs of both architectures tested under simulated physiological conditions (wetted at 37 °C). Both solid and porous PGS specimens could be modeled well with the Neo-Hookean model. Future studies include comparing PGS properties to other biological tissue types and designing and characterizing PGS scaffolds for regenerating these tissues. © 2012 Elsevier Ltd. Source


Kerber K.A.,500 East Medical Center Drive
CONTINUUM Lifelong Learning in Neurology | Year: 2012

Purpose of Review: This article describes an approach to the diagnosis and management of acute constant dizziness, one of the most unnerving presentations in medicine. Patients with acute constant dizziness can be completely debilitated by the symptoms. Most cases are caused by a self-limited disorder, typically vestibular neuritis. However, a significant proportion of cases harbor a stroke that could be life threatening. Discriminating a self-limited disorder from a life-threatening disorder can be challenging and often hinges on findings, which may be subtle, from the ocular motor examination.Recent Findings: Early research indicates that bedside ocular motor findings play a critical role in differentiating vestibular neuritis from stroke.Summary: This article describes an approach to the patient with acute constant dizziness. Copyright © American Academy of Neurology. Unauthorized reproduction of this article is prohibited. Source

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