Expert Review of Medical Devices

The 'Japanese paradox' of total hip arthroplasty: where are we going?
Oe K, Iida H and Saito T
There is a worldwide trend toward 'revisiting' cemented total hip arthroplasty (THA). In Japan, however, cemented THAs accounts for 11%, and the percentage of cemented hemiarthroplasty is estimated to be less than 10%. This review was designed to reconsider the option of cemented THA and to encourage policy changes in Japan to support the best possible care for patients.
Device profile of the Mobi-C artificial cervical disc: an overview of its safety and efficacy
Kim KD, Curran KA, Price RL and Khan S
The Mobi-C Cervical Disc Replacement is a motion preserving alternative to anterior cervical discectomy and fusion in properly indicated patients. In 2013, Mobi-C became the first cervical disc in the United States approved to treat more than one level of the cervical spine. The FDA determined Mobi-C to be statistically superior to fusion at two levels, based on the primary endpoint of a prospective, concurrently controlled and randomized multicenter clinical trial.
Assessment of glaucoma with retinal nerve fiber layer optical density ratios from volumetric optical coherence tomography across various analytical radii
Chen B, Chen S, Yang J and Zhang M
To explore the impact of glaucoma on the retinal nerve fiber layer (RNFL) optical density ratio (ODR) by volumetric optical coherence tomography (OCT) under different analytical radii.
Could one strategy fit all? A comparison of regulatory guidance from China, Europe, and the USA on medical device clinical evaluation throughout the total product lifecycle
Su G
The China National Medical Product Administration (NMPA), European Commission, and United States Food and Drug Administration (FDA) follow similar principles to establish regulatory requirements for medical device clinical evaluations throughout the total product lifecycle (TPLC). However, critical differences in these requirements may have led to different regulatory clinical evaluation strategies in the three jurisdictions. A thorough understanding of these differences is crucial for developing effective global regulatory strategies.
Techniques in hybrid repair of aortic arch and thoracoabdominal aortic pathologies
Archie MM, Archie MM and Khoynezhand A
Since the mid-1900s, techniques in the repair of aortic arch and thoracoabdominal aortic pathologies have drastically evolved. Open aortic surgical repair was once the sole option for both simple and complex aneurysmal degeneration. Today, a number of minimally invasive and hybrid approaches are now available to assist both the surgeon and patient in tackling this challenging problem.
A new horizon for aortic arch disease: the promise of total endovascular repair with triple-branched endografts
Niu Z, Cao L and Zhang H
Ablate and pace strategy for atrial fibrillation: pacing modalities, ablation approaches and impact on patient outcomes
Palmisano P, Mandurino C, Parlavecchio A, Luzzi G, Guido A, Accogli M and Coluccia G
In patients with symptomatic, refractory atrial fibrillation the ablate and pace (A&P) strategy (pacemaker implantation followed by atrio-ventricular junction ablation (AVJA)) is superior to medical therapy in improving quality of life and prognosis. Despite its well-proven benefits, this invasive therapeutic option is still underutilized in clinical practice. The choice of pacing modality (right ventricular pacing, biventricular pacing, BVP, or conduction system pacing, CSP) is crucial and can have significant clinical implications. In particular, in recent years CSP is emerging as an alternative to BVP, showing a good effectiveness and safety profile. Other important aspects are the timing of ablation, the approach used for AVJA, and the correct device programming after AVJA.
Comparative analysis of medical device adverse event reporting forms for patients and industries across various countries, and the introduction of a unified generic form for harmonization
Yadav AR, Pawar AR, Shete AS, Jadhav NR, Kumbhar AR, Jadhav NM and Gejage SM
This comparative study examines the complexities of adverse event reporting forms for medical devices across various nations. Despite rigorous clinical trials and surveillance techniques, variations persist in processes and data elements used to report adverse events. The study highlights the importance of standardizing adverse event reporting for medical devices and suggests a comprehensive 'Generic Adverse Event Reporting Form' to accurately determine causality. The advice encourages widespread use of this generic form to create a standardized and effective system for reporting adverse events related to medical devices.
Smart clothing for human movement analysis: future application in sport and clinical practice
Mason R, Barry G, Vitorio R, Lennon O, Robinson H, O'Callaghan B, Morris R, Godfrey A and Stuart S
Wearable technology in inflammatory bowel disease: current state and future direction
Harindranath S and Desai D
Wearables are electronic devices worn on the body to collect health data. These devices, like smartwatches and patches, use sensors to gather information on various health parameters. This review highlights the current use and the potential benefit of wearable technology in patients with inflammatory bowel disease (IBD).
Virtual reality therapy combined with physiological monitoring provides effective treatment, with objective metrics, for post-traumatic stress disorder
Wiederhold BK and Wiederhold MD
Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States
Metzger C, Hammond B, Ferro R, North J, Pyles S, Kranenburg A, Washabaugh E and Goldberg E
Fast-acting Sub-perception Therapy (FAST) is a novel spinal cord stimulation (SCS) modality delivering paresthesia-free pain relief. Our study evaluated the longer-term, real-world impact of FAST on chronic pain.
A retrospective study of reported adverse events associated with cardiac stents in Indian population
Mewada S, Shukla S, Soni M, Dahiya M, Kalaiselvan V, Reddy P, Mandloi AS and Dhote V
Cardiac stents are utilized to treat coronary artery diseases, a leading cause of death worldwide including in India. We investigated frequency and nature of adverse events (AEs) associated with cardiac stents in the Indian population.
Proactive esophageal cooling during radiofrequency cardiac ablation: data update including applications in very high-power short duration ablation
Sharkoski T, Zagrodzky J, Warrier N, Doshi R, Omotoye S, Mercado Montoya M, Gómez Bustamante T, Berjano E, González Suárez A, Kulstad E and Metzl M
Proactive esophageal cooling reduces injury during radiofrequency (RF) ablation of the left atrium (LA) for the treatment of atrial fibrillation (AF). New catheters are capable of higher wattage settings up to 90 W (very high-power short duration, vHPSD) for 4 s. Varying power and duration, however, does not eliminate the risk of thermal injury. Furthermore, alternative energy sources such as pulsed field ablation (PFA) also exhibit thermal effects, with clinical data showing esophageal temperatures up to 40.3°C. The ensoETM esophageal cooling device (Attune Medical, now a part of Haemonetics, Boston, MA, U.S.A.) is commercially available and FDA-cleared to reduce thermal injury to the esophagus during RF ablation for AF and is recommended in the 2024 expert consensus statement on catheter and surgical ablation of AF.
Amblyopia screening: the current state and opportunities for optimization
Morse J and Oatts JT
Amblyopia, the leading cause of monocular childhood vision loss, affects millions and is projected to increase. Early detection and treatment are crucial for preventing vision impairment.
Digital therapeutics as a new weapon against diseases: focus on the current European legislation and possible therapeutic strategies
Zovi A, Ferrara F, Gelmi M, Messina N, Pagani AAM, Patti T, Zanetti Lorenzetti E, Torri T and Langella R
Digital therapeutics (DTx) are an emerging phenomenon within the scientific landscape which is attracting considerable international interest. This review aimed to provide an overview of the definition and classification of DTx, focusing on the contribution that DTx may provide in the treatment of a lot of diseases, compared with pharmacological treatments and highlighting it strengthens and weaknesses into the European regulatory landscape.
Effects of elevated body mass index on the success of total knee and total hip arthroplasty: a comprehensive overview
Jevnikar BE, Ramos MS, Pasqualini I, Khan ST and Piuzzi NS
The average body mass index (BMI) in the United States has tripled over the last five decades despite concerted population-based efforts for weight management. Elevated BMI and, in particular, obesity are risk factors for osteoarthritis. This trend has led to increased demands for total knee (TKA) and total hip arthroplasty (THA), necessitating an in-depth understanding of how elevated BMI impacts TKA and THA.
Comparison of 6-lead smartphone ECG and 12-lead ECG in athletes and a genetic heart disease population
Davis AJ, Orchard JW, McGhie D, Broadbridge D, Raju H, La Gerche A, Puranik R, Gray B, De Jongh J, Driscoll T and Orchard JJ
Smartphone electrocardiograms (iECGs) are an innovative method of capturing transient arrhythmias that are occasionally experienced by athletes. This study aimed to assess the accuracy of a 6-lead iECG compared with 12-lead ECG in athletes and those with known genetic heart disease (positive controls).
Current status of routine use of veno-arterial extracorporeal membrane oxygenation during lung transplantation
Hauser BR, Estafanos M, Ayyat KS, Yun JJ and Elgharably H
Recently, there has been growing experience with utilizing a veno-arterial extracorporeal membrane oxygenator (VA ECMO) routinely during lung transplantation procedures. Yet, there is a lack of consensus on the protocols, benefits, and outcomes of routine VA ECMO use in lung transplantation.
Can digital health help improve medication adherence in cardiovascular disease?
Islam SMS, Maddison R, Karmarkar C and Rahman S
BComparison of supraglottic airway device vs. endotracheal intubation for initial airway management in out-of-hospital cardiac arrest: a systematic review and meta-analysis
Tao Y, Zhang J and Feng L
Out-of-hospital cardiac arrest (OHCA) is characterized by the cessation of mechanical cardiac activity and voluntary circulation occurring outside of a hospital setting, making it the leading cause of death worldwide. Recently, the optimal approach to airway management has been a subject of controversy.