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Regulatory science for medical devices aims to develop new tools, standards and approaches to assess the safety, effectiveness, quality and performance of medical devices. In the field of biomaterials, hernia mesh is a class of implants that have been successfully translated to clinical applications. With a focus on hernia mesh and its regulatory science system, this paper collected and reviewed information on hernia mesh products and biomaterials in both Chinese and American markets. The current development of regulatory science for hernia mesh, including its regulations, standards, guidance documents and classification, and the scientific evaluation of its safety and effectiveness was first reported. Then the research prospect of regulatory science for hernia mesh was discussed. New methods for the preclinical animal study and new tools for the evaluation of the safety and effectiveness of hernia mesh, such as computational modeling, big data platform and evidence-based research, were assessed. By taking the regulatory science of hernia mesh as a case study, this review provided a research basis for developing a regulatory science system of implantable medical devices, furthering the systematic evaluation of the safety and effectiveness of medical devices for better regulatory decision-making. This was the first article reviewing the regulatory science of hernia mesh and biomaterial-based implants. It also proposed and explained the concepts of evidence-based regulatory science and technical review for the first time.Vascular grafts must avoid negative inflammatory responses and thrombogenesis to prohibit fibrotic deposition immediately upon implantation and promote the regeneration of small diameter blood vessels ( less then 6 mm inner diameter). Here, polyurethane (PU) elastomers incorporating anti-coagulative and anti-inflammatory Gastrodin were fabricated. The films had inter-connected pores with porosities equal to or greater than 86% and pore sizes ranging from 250 to 400 μm. Ipatasertib chemical structure Incorporation of Gastrodin into PU films resulted in desirable mechanical properties, hydrophilicity, swelling ratios and degradation rates without collapse. The released Gastrodin maintained bioactivity over 21 days as assessed by its anti-oxidative capability. The Gastrodin/PU had better anti-coagulation response (less observable BSA, fibrinogen and platelet adhesion/activation and suppressed clotting in whole blood). Red blood cell compatibility, measured by hemolysis, was greatly improved with 2Gastrodin/PU compared to other Gastrodin/PU groups. Notably, Gastrodin/PU upregulated anti-oxidant factors Nrf2 and HO-1 expression in H2O2 treated HUVECs, correlated with decreasing pro-inflammatory cytokines TNF-α and IL-1β in RAW 264.7 cells. Upon implantation in a subcutaneous pocket, PU was encapsulated by an obvious fibrous capsule, concurrent with a large amount of inflammatory cell infiltration, while Gastrodin/PU induced a thinner fibrous capsule, especially 2Gastrodin/PU. Further, enhanced adhesion and proliferation of HUVECs seeded onto films in vitro demonstrated that 2Gastrodin/PU could help cell recruitment, as evidenced by rapid host cell infiltration and substantial blood vessel formation in vivo. These results indicate that 2Gastrodin/PU has the potential to facilitate blood vessel regeneration, thus providing new insight into the development of clinically effective vascular grafts.
There is widespread accord among economists that the corona virus disease 2019 (COVID-19) pandemic will have a severe negative effect on the global economy. Establishing new radiation therapy (RT) infrastructure may be significantly compromised in the post-COVID-19 era. Alternative strategies are needed to improve the existing RT accessibility without significant cost escalation. The outcomes of these approaches on RT availability have been examined for Asia.
The details of RT infrastructures in 2020 for 51 countries in Asia were obtained from the Directory of Radiotherapy Centers of the International Atomic Energy Agency. Using the International Atomic Energy Agency guidelines, the percent of RT accessibility and the additional requirements of teletherapy (TRT) units were computed for these countries. To maximize the utilization of the existing RT facilities, 5 options were evaluated, namely, hypofractionation RT (HFRT) alone, with/without 25% or 50% additional working hours. The effect of these strategie economic slowdown in the post-COVID-19 period could severely impend establishment of new RT facilities. Thus, maximal utilization of the available RT infrastructure with minimum additional costs could be possible by adopting HFRT with or without increased working hours to improve the RT coverage.
To report a rare case of acute lymphoblastic leukemia presenting with diplopia to an ophthalmologist.
A 29-year-old male patient presented to ophthalmology department with sudden onset of binocular diplopia in left gaze. Magnetic resonance imaging of brain and orbits revealed a thickened left medial rectus, with enhancement of right sixth nerve, bilateral third and fifth nerves. Bone marrow biopsy revealed acute lymphoblastic leukemia (ALL) with a Burkitt-type chromosomal translocation-t(8; 14) and the patient was started on chemotherapy.
This was a case of incomitant esotropia worse with left gaze due to left medial rectus infiltration mimicking a left sixth cranial nerve paresis. Diplopia can be the only presenting symptom of ALL and it can involve either an extraocular muscle or a cranial nerve.
This was a case of incomitant esotropia worse with left gaze due to left medial rectus infiltration mimicking a left sixth cranial nerve paresis. Diplopia can be the only presenting symptom of ALL and it can involve either an extraocular muscle or a cranial nerve.
To describe a case of anterior ischemic optic neuropathy as a presenting sign of granulomatosis with polyangiitis.
A previously healthy 50-year-old female developed right eye, then left eye, redness and pruritis and was diagnosed with allergic versus viral conjunctivitis. Five days later, she noted an acute decline in vision in the right eye, corresponding with a decrease on Snellen testing from 20/30 to 20/100 with correction. She was noted to have a right relative afferent pupillary defect, 2+ pallid disc edema, and OCT (Spectralis, Heidelberg Engineering, Carlsbad, CA) findings of significant retinal nerve fiber thickening. Review of systems revealed a three-month history fatigue, right-sided headaches, jaw claudication, bronchitis, cough without hemoptysis, and epistaxis, as well as interval development of a petechial rash across her body, migratory polyarthralgias, fevers, and tachycardia. ESR and CRP were markedly elevated, and the patient was admitted to the hospital for a systemic vasculitis workup.
Read More: https://www.selleckchem.com/products/gdc-0068.html
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