Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions
Expert Rev Med Devices. 2024 Apr 1:1-9. doi: 10.1080/17434440.2024.2337920. Online ahead of print.ABSTRACTINTRODUCTION: Repair of aortic arch pathologies such as degenerative aneurysms and dissections still represents a significant challenge for vascular and cardiac surgeons. We focused on the design, evolution, implementation, and prospects of endovascular dual branch technology for treatment of pathologies in the aortic arch.AREAS COVERED: The literature search was conducted in a non-systematic fashion through the PubMed and Scopus databases; articles deemed relevant to the scope of the work and fully published in Englis...
Source: Expert Review of Medical Devices - April 1, 2024 Category: Medical Devices Authors: Ciro Ferrer Giovanni Tinelli Mario D'Oria Source Type: research

Prolonged Preservation of Pediatric Size Hearts Using the VP.S ENCORE ® Hypothermic Oxygenated Machine Perfusion Device
Purpose: Research indicates that in the last decade, only 24% of class III medical devices were approved by the FDA for pediatric use, generally for children over the age of 12. Currently, pediatric patients in need of a heart transplant do not have access to organ preservation devices simply because there are no devices suitable for preserving pediatric-sized hearts with appropriate physiological flows and perfusion pressures. The purpose of this pilot study was to evaluate the safety of a novel, portable, simple-to-use hypothermic cardiac preservation device, the VP.S ENCORE ®, using pediatric-size porcine cardiac graft...
Source: The Journal of Heart and Lung Transplantation - April 1, 2024 Category: Transplant Surgery Authors: , K. Andrijauskaite, R.P. Lopez, Z. Maxwell, I. Cano, E.C. Cisneros, M. Basurto, G. Lamberson, L. Bunegin Source Type: research

Mechanical Effects of Medical Device Attachment to Human Tympanic Membrane
ConclusionThe findings of our study aid the development and optimization of new therapeutic devices, attached to the tympanic membrane, to have the least adverse effects on middle-ear vibrations. (Source: JARO - Journal of the Association for Research in Otolaryngology)
Source: JARO - Journal of the Association for Research in Otolaryngology - April 1, 2024 Category: ENT & OMF Source Type: research

Correction to: A digital teleneuropsychology platform for the diagnosis of mild cognitive impairment: from concept to certification as a medical device
(Source: Neurological Sciences)
Source: Neurological Sciences - April 1, 2024 Category: Neurology Source Type: research

Syringes for intraocular administration: Systematic review
CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.PMID:38556370 | DOI:10.1016/j.farma.2024.01.008 (Source: Farmacia Hospitalaria)
Source: Farmacia Hospitalaria - March 31, 2024 Category: Drugs & Pharmacology Authors: Ángela Pascual Carrasco Isabel Espadas Garc ía Ana Ram írez López Juan Selva Otaolaurruchi Source Type: research

Syringes for intraocular administration: Systematic review
CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.PMID:38556370 | DOI:10.1016/j.farma.2024.01.008 (Source: Farmacia Hospitalaria)
Source: Farmacia Hospitalaria - March 31, 2024 Category: Drugs & Pharmacology Authors: Ángela Pascual Carrasco Isabel Espadas Garc ía Ana Ram írez López Juan Selva Otaolaurruchi Source Type: research

Syringes for intraocular administration: Systematic review
CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.PMID:38556370 | DOI:10.1016/j.farma.2024.01.008 (Source: Farmacia Hospitalaria)
Source: Farmacia Hospitalaria - March 31, 2024 Category: Drugs & Pharmacology Authors: Ángela Pascual Carrasco Isabel Espadas Garc ía Ana Ram írez López Juan Selva Otaolaurruchi Source Type: research

A Sponsor ’s Perspective on the Contribution of Regulatory-Required Observational Post-Marketing Studies to Understanding Human Drug Product Benefit/Risk in Japan
ConclusionsThe reexamination process did not result in regulatory changes for any of the examined drugs. The Japan new-drug application (J-NDA) review and approval process, including implementation of the initial Japan product label, assures acceptable benefit/risk at the time of approval such that mandatory GDUI or SI studies for all products should be reconsidered. In the case of genuine scientific uncertainty to the extent that the benefit/risk of the product is not clear, a PMS is warranted. (Source: Pharmaceutical Medicine)
Source: Pharmaceutical Medicine - March 31, 2024 Category: Drugs & Pharmacology Source Type: research

Contact Allergy to Allergens in the Swedish Baseline Series Overrepresented in Diabetes Patients with Skin Reactions to Medical Devices - A Retrospective Study from Southern Sweden
In conclusion, not only medical device-related contact allergies, but also contact allergy to baseline series allergens (fragrance mix II and sesquiterpene lactone mix), is overrepresented in diabetes patients who use medical devices.PMID:38551376 | DOI:10.2340/actadv.v104.19676 (Source: Acta Derm Venereol A...)
Source: Acta Derm Venereol A... - March 29, 2024 Category: Dermatology Authors: Josefin Ulriksdotter Thanisorn Sukakul Magnus Bruze Martin Mowitz Robert Ofenloch Cecilia Svedman Source Type: research

Contact Allergy to Allergens in the Swedish Baseline Series Overrepresented in Diabetes Patients with Skin Reactions to Medical Devices - A Retrospective Study from Southern Sweden
In conclusion, not only medical device-related contact allergies, but also contact allergy to baseline series allergens (fragrance mix II and sesquiterpene lactone mix), is overrepresented in diabetes patients who use medical devices.PMID:38551376 | DOI:10.2340/actadv.v104.19676 (Source: Acta Dermato-Venereologica)
Source: Acta Dermato-Venereologica - March 29, 2024 Category: Dermatology Authors: Josefin Ulriksdotter Thanisorn Sukakul Magnus Bruze Martin Mowitz Robert Ofenloch Cecilia Svedman Source Type: research

Contact Allergy to Allergens in the Swedish Baseline Series Overrepresented in Diabetes Patients with Skin Reactions to Medical Devices - A Retrospective Study from Southern Sweden
In conclusion, not only medical device-related contact allergies, but also contact allergy to baseline series allergens (fragrance mix II and sesquiterpene lactone mix), is overrepresented in diabetes patients who use medical devices.PMID:38551376 | DOI:10.2340/actadv.v104.19676 (Source: Acta Derm Venereol A...)
Source: Acta Derm Venereol A... - March 29, 2024 Category: Dermatology Authors: Josefin Ulriksdotter Thanisorn Sukakul Magnus Bruze Martin Mowitz Robert Ofenloch Cecilia Svedman Source Type: research

Economic Impact of COVID-19 on a Free-Standing Pediatric Ambulatory Center
CONCLUSION: Our study identified specific economic impacts of COVID-19 on free-standing pediatric ambulatory centers, thereby highlighting the need for innovative practices with cost containment for sustainability of such specialized centers when dealing with future pandemics related to COVID-19 or other viral pathogens.PMID:38550553 | PMC:PMC10970035 | DOI:10.14740/jocmr5083 (Source: Clin Med Res)
Source: Clin Med Res - March 29, 2024 Category: Research Authors: Connor Randall Christian Mpody Vidya T Raman Olubukola O Nafiu Joseph D Tobias Source Type: research

Contact Allergy to Allergens in the Swedish Baseline Series Overrepresented in Diabetes Patients with Skin Reactions to Medical Devices - A Retrospective Study from Southern Sweden
In conclusion, not only medical device-related contact allergies, but also contact allergy to baseline series allergens (fragrance mix II and sesquiterpene lactone mix), is overrepresented in diabetes patients who use medical devices.PMID:38551376 | DOI:10.2340/actadv.v104.19676 (Source: Acta Dermato-Venereologica)
Source: Acta Dermato-Venereologica - March 29, 2024 Category: Dermatology Authors: Josefin Ulriksdotter Thanisorn Sukakul Magnus Bruze Martin Mowitz Robert Ofenloch Cecilia Svedman Source Type: research

Remote Therapeutic Monitoring in Rheumatic and Musculoskeletal Diseases: Opportunities and Implementation
Med Res Arch. 2023 Jul;11(7.2):3957. doi: 10.18103/mra.v11i7.2.3957.ABSTRACTTherapeutic Monitoring (RTM) is a new program in the United States that began in 2022 allowing electronic patient-reported outcomes (ePRO) and other patient-generated data to be reviewed by clinical staff between visits so that patients can receive clinical attention as needed. Remote Therapeutic Monitoring simultaneously enhances the capacity to generate prospective longitudinal data that may be useful for secondary research purposes. As many governmental and private insurance programs in the United States now provide reimbursement for Remote Ther...
Source: Pain Physician - March 29, 2024 Category: Anesthesiology Authors: W Benjamin Nowell Jeffrey R Curtis Source Type: research

Which way forward? Comparing radiological outcomes using three different surgical approaches in robotic assisted total hip arthroplasty
CONCLUSION: Robotic assistance in THA, especially via the DAA approach, enhances the accuracy and precision of acetabular component positioning. Consistent registration accuracy across various surgical approaches confirms the reliability of these methods for THA.CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifier is ChiCTR2100044124.PMID:38551127 | DOI:10.1080/17434440.2024.2334932 (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - March 29, 2024 Category: Medical Devices Authors: Zhang Xianzuo Shen Xianyue Abasi Maimaitiabula Zhang Zian Zhang Haining Yang Bo Zhu Chen Source Type: research