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Novel approaches to obesity prevention among youth are needed. Accordingly, the Office of Women's Health, Department of Health and Human Services, sponsored a challenge to create an interactive video game for obesity prevention. Our team took a theory-based, evidence-informed approach to increasing physical activity in girls. Our approach-digitally mediated physical play-allowed us to include computing-based strategies that promote activity without keeping players in front of a screen. Our prize-winning prototype app, Frolic, helps girls choose the perfect game to play in any context, engaging parents for support. The app is used to highlight some opportunities and challenges for interdisciplinary collaboration. However, much work remains to be done to deploy innovative digital obesity interventions and fully capture the contributions of these tools. In order to accelerate advances, funding is needed for projects that combine engineering design principles with traditional obesity research paradigms., (© 2021 The Obesity Society.)

Vision restoration is an ideal medical application for optogenetics, because the eye provides direct optical access to the retina for stimulation. Optogenetic therapy could be used for diseases involving photoreceptor degeneration, such as retinitis pigmentosa or age-related macular degeneration. We describe here the selection, in non-human primates, of a specific optogenetic construct currently tested in a clinical trial. We used the microbial opsin ChrimsonR, and showed that the AAV2.7m8 vector had a higher transfection efficiency than AAV2 in retinal ganglion cells (RGCs) and that ChrimsonR fused to tdTomato (ChR-tdT) was expressed more efficiently than ChrimsonR. Light at 600 nm activated RGCs transfected with AAV2.7m8 ChR-tdT, from an irradiance of 10 15 photons.cm -2 .s -1 . Vector doses of 5 × 10 10 and 5 × 10 11 vg/eye transfected up to 7000 RGCs/mm 2 in the perifovea, with no significant immune reaction. We recorded RGC responses from a stimulus duration of 1 ms upwards. When using the recorded activity to decode stimulus information, we obtained an estimated visual acuity of 20/249, above the level of legal blindness (20/400). These results lay the groundwork for the ongoing clinical trial with the AAV2.7m8 - ChR-tdT vector for vision restoration in patients with retinitis pigmentosa.

Ovarian cancer surgery endeavours to remove all visible tumour deposits, and surgical technologies could potentially facilitate this aim. However, there appear to be barriers around the adoption of new technologies, and we hope this article provokes discussion within the specialty to encourage a forward-thinking approach to new-age surgical gynaecological oncology.

Objective: The objective of this study was to report the 5-year outcomes of the Food and Drug Administration investigational device exemption clinical trial of endovascular aneurysm repair (EVAR) with the Ovation stent graft (Endologix, Irvine, Calif) for elective treatment of abdominal aortic aneurysm (AAA)., Methods: The study comprised 161 patients who underwent EVAR as part of the prospective, international, multicenter pivotal Ovation stent graft trial. The main inclusion criteria were AAA diameter ≥5 cm, proximal neck length ≥7 mm, neck angulation ≤60 degrees, and bilateral iliac fixation length ≥10 mm. The primary end point was a composite outcome of primary clinical success at 5 years. Primary clinical success was defined in accordance with the Society for Vascular Surgery guidelines as successful aneurysm exclusion without aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion, aneurysm rupture, graft migration, or conversion to open repair. Secondary end points included freedom from reintervention, all-cause mortality, and aneurysm-related mortality., Results: Patients were predominantly male (87.6%) and elderly with a mean age of 73 ± 7.7 years; 66 patients (41%) had challenging anatomy and would be considered outside the instructions for use with other stent grafts, 26 (16.2%) had a proximal neck length <10 mm, and 53 (33%) had a minimum access vessel diameter <6 mm. Technical success was 100%. Of 126 surviving patients, 84 (66.7%) completed 5-year follow-up. The 5-year primary clinical success rate was 78%, aneurysm-related mortality was 1% (one patient), and all-cause mortality was 25%. The AAA-related death resulted from AAA post-EVAR rupture at 49 months in a patient who refused treatment for a type IB endoleak. Freedom from type I or type III endoleak was 95.1%. Freedom from secondary interventions was 80.2%. Most of the reinterventions were performed for type II endoleak (24 [63.1%]) or for limb thrombosis or stenosis (7 [18.4%]). There was no graft migration. None of the patients required open conversion., Conclusions: Five-year results from the Ovation pivotal and continued access investigational device exemption trials demonstrate excellent long-term durability of this endograft despite that 41% of patients had anatomy unfit for other stent grafts. There were no migrations or conversions to open repair and 99% freedom from aneurysm-related mortality. These results suggest a less invasive on-label endovascular option for patients with challenging anatomy who may otherwise require hybrid or open repair., (Published by Elsevier Inc.)

Recently rechargeable devices have been introduced for sacral neuromodulation (SNM) with conditional safety for full-body magnetic resonance imaging (MRI). Currently a recharge-free SNM device represents the standard implant; however, it is only approved for MRI head scans. As further new technologies with broader MRI capabilities are emerging, the advantages as well as disadvantages of both rechargeable versus recharge-free devices will be briefly discussed in this commentary from the perspective of patients, healthcare professionals, and providers.

This review highlights the contributions of American oral and maxillofacial surgeons to the field of orthognathic surgery. The present state of the art and science of orthognathic surgery is the harvest of yesterday's innovation and research. An improved understanding of the biological and surgical principles and the routine involvement of orthodontics have fueled widespread adoption of a coordinated approach to the treatment of dentofacial problems. Technologic advances in rigid internal fixation, virtual surgical planning with computer-aided manufacturing of occlusal splints and cutting guides, custom implants, and worldwide interest in the correction of dentofacial and craniofacial deformities have resulted in highly predictable, efficient, and safe treatment, which scarcely resembles the situation 70 years ago., (Copyright © 2018 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.)

Background and Objective: Qualitative methods such as semi-structured interviews and focus-groups are used to evaluate the applicability and relevance of device technologies in clinical practice, but when used alone, often lack generalizability. This study aimed to assess the face validity and feasibility of using a composite, three-step qualitative method (the Parker Model), to inform the development and implementation of ava ® , an electromechanical device (e-Device) for subcutaneous self-administration of the biologic, certolizumab pegol (CZP), used to treat rheumatic diseases., Methods: The Parker Model combines concept mapping (CM), participatory design (PD), and stakeholder evaluation (SE). CM, a structured group process, was used to identify patients' opinions and concerns regarding the e-Device. Patients used this information in iterative PD sessions to create personal e-Device prototypes in cooperation with a designer and a healthcare professional. SE was performed based on semi-structured group and individual interviews with patients and disease-management stakeholders., Results: The study recruited 14 patients, two doctors, two nurses, one medical secretary, and four other public servants. Three CM workshops revealed four key considerations: technical usability, physical design, concerns, and enthusiasm. Four personalized prototypes were developed during PD sessions. SE confirmed that the identified considerations were pivotal for the implementation and adaptation of the e-Device., Conclusions: This study is the first to apply a composite, qualitative research model when introducing an e-Device for the treatment and management of rheumatic disease. Results show that input from patients and other stakeholders using the Parker Model can add value to the development and implementation of an e-Device.

Clinical and subclinical mastitis affects 30% of cows and is regarded as the most significant economic burden on the dairy farm reducing milk yield and quality and increasing culling rate. A proprietary Acoustic Pulse Therapy (APT) device was developed specifically for treating dairy cows. The APT device was designed to produce deep penetrating acoustic pulses that are distributed over a large treated area at a therapeutic level. This paper presents findings from a clinical assessment of this technology for the treatment of dairy cows with subclinical and clinical mastitis. In subclinical mastitis, a group of 116 cows from 3 herds were identified with subclinical intramammary infection and enrolled in the study; 78 cows were assigned to the treatment group and 38 cows to the control group. Significant differences (P<0.001) were found where 70.5% of the cows in the treatment group returned to normal milk production, compared with only 18.4% of the control group. Daily milk yields of the treated cows increased significantly (P<0.05) and the percentage of cows with log somatic cell count under 5.6 cells/mL was significantly higher (P<0.001). Milk of the infected quarters appeared normal with lactose greater than 4.8%, but this difference was not significant. Of the treated cows with identified bacteria, 52.6% of the quarters were cured, while in the control group only 25.0% (P<0.001). Specifically, all cows identified with Escherichia coli in the treatment group were cured, with 66.6% cured with no intervention in the control. Spontaneous cure of glands infected with coagulase negative staphylococci (CNS) and Streptococci was low while treatment successfully increased the cure of CNS from 13.3% to 53.8% and that of Streptococci from 18.2% to 36.4%. Of the 4 cows identified with Staphylococcus aureus, 3 were cured. The clinical mastitis study group included 29 infected cows that were submitted either to a gold standard antibiotic treatment subgroup of 16 cows (n = 16) or to an APT treatment subgroup of 13 cows (n = 13). A cure of 18.7% was shown for the antibiotic treatment, of which logSCC returned to <5.6 cell/mL and 56.2% were culled. A cure of 76.9% was shown for the APT treatment with only one cow culled (7.7%)., Competing Interests: We have the following interests. The study was funded by Hi-Impacts LTD., the employer of E Papirov and S Shefy who are shareholders of the company. E Papirov is also a board member of Hi-Impacts who have a financial interest in the study since Hi-Impacts holds the rights to the patent use. This study was performed following patented invention of an APT device (Patent no.: US 9498236 - High pressure ballistic extracorporeal shockwave device, system and method of use). This is a first trial of a new technology in dairy husbandry. We see commercial potential of the APT technology. There are no further patents and products in development or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.

Important advances are afoot in the field of neurosurgery-particularly in the realms of deep brain stimulation (DBS), deep brain manipulation (DBM), and the newly introduced refinement "closed-loop" deep brain stimulation (CLDBS). Use of closed-loop technology will make both DBS and DBM more precise as procedures and will broaden their indications. CLDBS utilizes as feedback a variety of sources of electrophysiological and neurochemical afferent information about the function of the brain structures to be treated or studied. The efferent actions will be either electric, i.e. the classic excitatory or inhibitory ones, or micro-injection of such things as neural proteins and transmitters, neural grafts, implants of pluripotent stem cells or mesenchymal stem cells, and some variants of gene therapy. The pathologies to be treated, beside Parkinson's disease and movement disorders, include repair of neural tissues, neurodegenerative pathologies, psychiatric and behavioral dysfunctions, i.e. schizophrenia in its various guises, bipolar disorders, obesity, anorexia, drug addiction, and alcoholism. The possibility of using these new modalities to treat a number of cognitive dysfunctions is also under consideration. Because the DBS-CLDBS technology brings about a cross-fertilization between scientific investigation and surgical practice, it will also contribute to an enhanced understanding of brain function., (Copyright © 2017. Published by Elsevier Inc.)

Recent advances in deep brain stimulators and brain-machine interfaces have greatly expanded the possibilities of neuroprosthetics and neuromodulation. Together with advances in neuroengineering, nanotechnology, molecular biology and material sciences, it is now possible to address fundamental questions in neuroscience in new, more powerful ways. It is now possible to apply these new technologies in ways that range from augmenting and restoring function to neuromodulation modalities that treat neuropsychiatric disorders. Recent developments in neuromodulation methods offer significant advantages and potential clinical benefits for a variety of disorders. Here we describe the current state of the art in neuromodulation methods, and some advances in brain-machine interfaces, describing the advantages and limitations of the clinical applications of each method. The future applications of these new methods and how they will shape the future of psychiatry and medicine, along with safety and ethical implications, are also discussed., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objective: Cyanoacrylate closure (CAC) was shown in the recently published VenaSeal Sapheon Closure System vs Radiofrequency Ablation for Incompetent Great Saphenous Veins (VeClose) randomized clinical study to be an effective and noninferior option (in terms of both safety and effectiveness) to radiofrequency ablation (RFA) in the treatment of incompetent great saphenous veins. The objectives of this analysis were to report the efficacy and safety outcomes of the VeClose roll-in (training) group treated with CAC by physicians who had received device use training but had no prior treatment experience with the technique and to compare the outcomes with those from the randomized RFA and CAC groups., Methods: The first two subjects at each participating site (n = 20) were roll-in cases (ie, not randomized but instead treated with CAC) to ensure the physician's familiarity with the procedure. Subsequent eligible subjects were randomized to either CAC or RFA. After treatment, all subjects returned for assessment on day 3 and months 1, 3, 6, and 12. The study's primary end point was complete closure of the target vein at month 3. Secondary analyses included patient-reported intraprocedural pain and investigator-rated ecchymosis at day 3. Additional assessments included procedure time, quality of life surveys, and adverse events., Results: Mean procedure time was longer in the roll-in group (31 minutes) compared with the randomized groups (24 minutes for CAC and 19 minutes for RFA; P < .0001). Procedure time decreased in both the CAC and RFA groups over time, plateauing at about 22 minutes for CAC and 15 minutes for RFA. In the roll-in group, the 3-month complete occlusion rate was 100%. Reported intraprocedural pain ratings were similar between the roll-in and randomized groups. Other clinical assessments, including quality of life improvement and adverse events, were similar between the roll-in and randomized groups. Increasing procedure number did not affect clinical outcomes., Conclusions: The results from the VeClose study roll-in group demonstrate that despite the physician's lack of prior experience, initial treatment with CAC leads to comparable efficacy and safety results to RFA and is associated with a relatively short learning period., (Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objective:  To evaluate safety alerts and recalls, publication of key trial outcomes, and subsequent US approval of high profile medical devices introduced in the European Union., Design:  Cohort study., Setting:  Novel cardiovascular, orthopedic, and neurologic devices approved in the EU through Conformité Européenne marking between 2005 and 2010., Data Sources:  Public and commercial databases searched up to January 2016 for press releases and announcements of approvals; public Food and Drug Administration and European regulatory authority databases for US approvals and safety alerts and recalls; and Medline, Embase, and Web of Science for peer reviewed publications., Main Outcome Measures:  We categorized the novelty of the devices in the study sample as a "major innovation" or an "other change," and extracted descriptive data about the devices and information on any safety alerts and withdrawals. Linear regression models examined factors associated with differential EU and US approvals. Cox proportional hazards regression models were used to evaluate factors associated with safety alerts and recalls and the publication of trial outcomes for devices categorized as major innovations. Models controlled for time, therapeutic category, regulatory pathway, size of sponsoring company, and indicator variables for devices approved first in the EU and devices approved only in the EU., Results:  67% (206/309) of devices identified were approved in both the US and the EU, of which 63% (129/206) were approved first in the EU. The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices approved first in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval 1.4 to 6.2) for devices approved first in the EU. The results of pivotal trials were published for 49% (37/75) of devices categorized as major innovations, with an overall publication rate of 37% five years after approval., Conclusions:  Devices approved first in the EU are associated with an increased risk of post-marketing safety alerts and recalls. Poor trial publication rates mean that patients and clinicians need greater regulatory transparency to make informed decisions about treatment., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Epicutaneous immunotherapy is a developing technique, aiming at desensitizing patients with food allergy with less risks that oral ingestion or injection could generate. Several clinical trials have been performed and are currently running, in milk and peanut allergy, assessing the safety of the technique and its efficacy. Preclinical models indicate a major role in the mechanisms of desensitization, for example, Tregs and epigenetic modifications.

Manufacturers launching next-generation or innovative medical devices in Europe face a very heterogeneous reimbursement landscape, with each country having its own pathways, timing, requirements and success factors. We selected 2 markets for a deeper look into the reimbursement landscape: France, representing a country with central decision making with defined processes, and Italy, which delegates reimbursement decisions to the regional level, resulting in a less transparent approach to reimbursement. Based on our experience in working on various new product launches and analyzing recent reimbursement decisions, we found that payers in both countries do not reward improved next-generation products with incremental reimbursement. Looking at innovations, we observe that manufacturers face a challenging and lengthy process to obtain reimbursement. In addition, requirements and key success factors differ by country: In France, comparative clinical evidence and budget impact very much drive reimbursement decisions in terms of pricing and restrictions, whereas in Italy, regional key opinion leader (KOL) support and additional local observational data are key., (© 2015 Diabetes Technology Society.)

The work was aimed at assessing efficacy and safety of indications for and contraindications to a promising method of treatment for multifocal atherosclerosis - enforced external counterpulsation, suggesting a new noninvasive method of treatment of chronic obliterating diseases of lower-limb arteries - cardiosynchronized sequential antegrade pneumocompression.

The work is dedicated to a new method of treatment for chronic obliterating diseases of lower limb arteries - cardiosynchronized sequential antegrade pneumocompression. The author describes the basic principles of the method, its physiological effects, and the results of treatment on volunteers.

Antidepressant treatments, including pharmacotherapy and psychotherapy, do not result in remission for the majority of patients with major depressive disorder. The high prevalence of treatment resistant depression (TRD) poses a significant issue for patients as well as both societal and economic costs. Due to the limited efficacy of existing therapies in this sub-population, alternative somatic treatments are being explored. Both vagus nerve stimulation (VNS) and deep brain stimulation (DBS) are neurostimulation treatments for TRD. While VNS has Food Drug Administration approval as an adjunctive therapy for MDD, DBS is still in the experimental stages. This article will review the evidence supporting the clinical utility of these therapies.

Magnetic seizure therapy (MST) is a novel neurotherapeutic intervention in development for the treatment of major affective disorders. Like other neurotherapeutic strategies such as electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS), a primary interest will be to monitor the associated neurocognitive effects. Thus, the purpose of this systematic review was to synthesize the available data on the neurocognitive effects of MST. The authors performed two independent literature searches with the following terms terms: MST, magnetic, magnetic seizure therapy, depression, neurocognition, cognitive, preclinical. We included in this review a total of eleven articles that mentioned MST and neurocognition in the abstract. The articles were divided into three methodological domains that included virtual computer simulations, preclinical studies, and clinical investigations. Collectively, the available evidence suggests MST has little to no adverse cognitive effects. Specifically, virtual computer simulations found the magnetic field was localized to grey matter, and preclinical studies found no neurocortical or neurocognitive sequelae. Clinical investigations found MST to be associated with rapid reorientation and intact anterograde and retrograde memory. Future investigations using translational methods are warranted to confirm these findings and to further determine the effects of MST on neurocognitive functions.

Patients treated by pediatric interventional cardiologists and cardiac surgeons often have unmet medical device needs that pose a challenge to the current regulatory evaluation and approval process in the United States. In this report we review current US Food and Drug Administration regulatory processes, review some unique aspects of pediatric cardiology and cardiac surgery that pose challenges to these processes, and discuss possible alternate pathways to cardiac device evaluation and approval for children. Children deserve to benefit from new and refined cardiac devices and technology designed explicitly for their conditions.

New features of mechanical ventilators are frequently introduced, including new modes, monitoring techniques, and triggering techniques. But new rarely translates into any measureable improvement in outcome. We describe 4 new techniques and attempt to define what is a new invention versus what is innovative-a technique that significantly improves a measurable variable. We describe and review the literature on automated weaning, automated measurement of functional residual capacity, neural triggering, and novel displays of respiratory mechanics.

In the United States,the Food and Drug Administration (FDA) and the National Institutes of Health have noted a significant decrease in the number of innovative products reaching patients, in spite of a rapidly expanding basis of fundamental scientific knowledge. A recent FDA report proposes some solutions to this problem.

In April 2002, after extensive ex-vivo and animal implantation studies, we performed the first successful implantation of a new percutaneous aortic valve in a patient with endstage aortic stenosis. The purpose of this article is to give a detailed description of the technique of percutaneous implantation of aortic valve bioprosthesis in patients with severe calcific aortic stenosis. Antegrade transeptal approach was used under local anesthesia and mild sedation.

Compliance officers and financial managers should forge an alliance to ensure their organization's ethics and integrity. Many financial and compliance issues stem from clinical research. Billing for experimental devices must follow specific rules, especially when payment is from Medicare. The charge description master should receive detailed attention to improve efficiency and net revenues. Violations of protected health information can have serious financial implications.

Background: The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed. After ex vivo testing and animal implantation studies, the first human implantation was performed in a 57-year-old man with calcific aortic stenosis, cardiogenic shock, subacute leg ischemia, and other associated noncardiac diseases. Valve replacement had been declined for this patient, and balloon valvuloplasty had been performed with nonsustained results., Methods and Results: With the use of an antegrade transseptal approach, the PHV was successfully implanted within the diseased native aortic valve, with accurate and stable PHV positioning, no impairment of the coronary artery blood flow or of the mitral valve function, and a mild paravalvular aortic regurgitation. Immediately and at 48 hours after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of 4 months, the valvular function remained satisfactory as assessed by sequential transesophageal echocardiography, and there was no recurrence of heart failure. However, severe noncardiac complications occurred, including a progressive worsening of the leg ischemia, leading to leg amputation with lack of healing, infection, and death 17 weeks after PHV implantation., Conclusions: Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement. After further device modifications, additional durability tests, and confirmatory clinical implantations, PHV might become an important therapeutic alternative for the treatment of selected patients with nonsurgical aortic stenosis.