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Expert Review of Medical Devices May 2024Expandable devices such as interbody cages, vertebral body reconstruction cages, and intravertebral body expansion devices are frequently utilized in spine surgery.... (Review)
Review
INTRODUCTION
Expandable devices such as interbody cages, vertebral body reconstruction cages, and intravertebral body expansion devices are frequently utilized in spine surgery. Since the introduction of expandable implants in the early 2000s, the variety of mechanisms that drive expansion and implant materials have steadily increased. By examining expandable devices that have achieved commercial success and exploring emerging innovations, we aim to offer an in-depth evaluation of the different types of expandable cages used in spine surgery and the underlying mechanisms that drive their functionality.
AREAS COVERED
We performed a review of expandable spinal implants and devices by querying the National Library of Medicine MEDLINE database and Google Patents database from 1933 to 2024. Five major types of mechanical jacks that drive expansion were identified: scissor, pneumatic, screw, ratchet, and insertion-expansion.
EXPERT OPINION
We identified a trend of screw jack mechanism being the predominant machinery in vertebral body reconstruction cages and scissor jack mechanism predominating in interbody cages. Pneumatic jacks were most commonly found in kyphoplasty devices. Critically reviewing the mechanisms of expansion and identifying trends among effective and successful cages allows both surgeons and medical device companies to properly identify future areas of development.
Topics: Humans; Spine; Prostheses and Implants; Orthopedic Procedures
PubMed: 38557229
DOI: 10.1080/17434440.2024.2337295 -
Heart Rhythm Sep 2023Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing...
Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.
Topics: Humans; Defibrillators, Implantable; Remote Sensing Technology
PubMed: 37211145
DOI: 10.1016/j.hrthm.2023.03.1525 -
Advanced Healthcare Materials Jan 2024The advancement and extensive demand for transdermal therapies can benefit from a safe, and efficient and user-friendly transdermal technology with broad applicability...
The advancement and extensive demand for transdermal therapies can benefit from a safe, and efficient and user-friendly transdermal technology with broad applicability in delivering various hydrophilic drugs. Here the design and proof of concept applications of an ultraswelling microneedle device that enables the facile and efficient loading and transdermal delivery of hydrophilic drugs with different molecular weights is reported. The device consists of a super-hydrophilic hydrogel microneedle array and a resin base substrate. Using a special micromolding technique that involves hydrated crosslinking and cryogenic-demolding, the microneedle part displays a rapid swelling ratio of ≈3800%, enabling the loading of drugs up to 500 kDa in molecular weight. The drug loading process using the device just involves incubating the microneedle part in a drug solution for 1 min, followed by 15 min of drying. The microneedles can easily penetrate the skin under press and detach from the base substrate under shear, thereby releasing the payload. Administration of desired therapeutic agents using the device outperformed conventional administration methods in mitigating psoriasis and eliciting immunity. This biocompatible device, capable of withstanding ethylene oxide sterilization, can enhance the efficacy and accessibility of transdermal therapies in research institutes, hospitals, and even home settings.
Topics: Needles; Microinjections; Administration, Cutaneous; Skin; Hydrogels; Drug Delivery Systems
PubMed: 37861278
DOI: 10.1002/adhm.202302406 -
Surgical Innovation Oct 2023Clinical trials represent a significant risk in the commercialization of surgical technologies. There is incentive for companies to mitigate their regulatory risk by...
BACKGROUND
Clinical trials represent a significant risk in the commercialization of surgical technologies. There is incentive for companies to mitigate their regulatory risk by targeting 510K over Premarket Approval (PMA) pathways in order to limit the scope, complexity and cost of clinical trials. As such, not all companies will publish clinical data in the scientific literature.
PURPOSE
We set out to investigate the relationship between scientific publication by surgical device companies and the impact it has on company valuation. We hypothesize that publishing in the scientific literature correlates with success of the surgical device companies as measured by funding.
RESEARCH DESIGN
We first obtained a list of surgical device startup companies and their financial deals using the Pitchbook database. Those companies were then cross referenced with the FDA database and the Dimensions database for product registrations and peer reviewed publications, respectively. Analysis was then performed using these query results.
STUDY SAMPLE AND DATA COLLECTION
We obtained a list of US surgical device startups financing deals closed between 2010 and 2020 from the Pitchbook database. We queried the Pitchbook for deal dates from January 1, 2010 to January 1, 2020 for deal types spanning early stage investment to IPO. Deals were limited to those conducted in the United States and to the surgical device industry. We queried the FDA database for product registration information associated with each of the companies involved in the deals. We tabulated the number of journal articles associated with surgical device companies using the Dimensions Search API as well as a manual confirmation.
RESULTS
Five hundred thirty five (535) deals from 222 companies were found in Pitchbook that met our criteria. Querying the FDA database resulted in 578 registrations associated with these companies. Publications per company ranged widely.
CONCLUSIONS
Companies that are able to generate a more numerous publications had correspondingly higher valuations during funding rounds. A subset of outstanding companies were analyzed and at least four factors affect: direct value of publications, indirect valve of publications, survivorship bias, and adoption share; each of which will be discussed in this manuscript.
Topics: United States; Equipment and Supplies; General Surgery; Publications; Industry
PubMed: 36511818
DOI: 10.1177/15533506221143267 -
International Wound Journal Sep 2023The aim of this review study is to investigate the nurses' knowledge and related factors towards the prevention of medical device-related pressure ulcers (MDRPUs). An... (Review)
Review
The aim of this review study is to investigate the nurses' knowledge and related factors towards the prevention of medical device-related pressure ulcers (MDRPUs). An extensive search was conducted in international electronic databases such as PubMed, Web of Science, and Scopus, and Persian databases, such as Iranmedex and the Scientific Information Database from December 1, 2022. During this search, keywords extracted from Medical Subject Headings, such as "Prevention knowledge," "Nurse," "Pressure ulcer," "Equipment and Supplies," and "Intensive Care Units" were used. The quality of the present studies in this review was evaluated based on the appraisal tool for cross-sectional studies (AXIS tool). A total of 1847 nurses participated in this review from five studies, and the majority of them (82.94%) were female. The mean age of the participants was 31.40 (SD = 5.97). The mean score of MDRPUs prevention knowledge in nurses based on PU2014 scale and researcher-made questionnaires were 16.50 (SD = 3.74) out of 31 and 65.49 (SD = 6.33) out of 100, respectively. The knowledge of nurses is influenced by factors such as age, sex, level of education, work experience, technical titles, type of hospital, level of hospital, and type of ward. Various factors had a significant positive relationship with nurses' MDRPUs prevention knowledge, which includes level of education, work experience, previous training on MDRPU, having a wound care certificate, an online search about MDRPU, and attitude and practise towards MDRPU prevention. At the same time, nurses' knowledge about the prevention of MDRPUs had a significant negative relationship with the time interval since last participating in MDRPU training or workshop. Overall, the level of MDRPUs prevention knowledge among nurses was insufficient to moderate. Therefore, it is suggested to provide facilities for nurses to receive the necessary training.
Topics: Humans; Male; Female; Pressure Ulcer; Cross-Sectional Studies; Clinical Competence; Attitude of Health Personnel; Hospitals; Surveys and Questionnaires; Health Knowledge, Attitudes, Practice; Nurses
PubMed: 36792930
DOI: 10.1111/iwj.14122 -
Journal of Tissue Viability May 2024This study aimed to determine the incidence, severity and characteristics of medical device-related pressure injuries in intensive care units.
AIM
This study aimed to determine the incidence, severity and characteristics of medical device-related pressure injuries in intensive care units.
METHODS
This is a cross-sectional study. Data were collected from 187 patients admitted to the Anaesthesia and Reanimation intensive care unit of a university hospital between January and May 2023. The skin of the patients enrolled in the study was assessed for the presence of medical device-related pressure injuries, and all medical devices used were recorded. Data were collected using the Patient Identification Form, the Medical Device-Related Pressure Injury Follow-up Form, and the Braden Scale for Predicting Pressure Ulcer Risk.
RESULTS
It was found that 30.6% of the patients developed medical device-related pressure injuries; of these, 73.7% had stage I pressure injuries. We found that 36.8% of the patients were diagnosed with medical device-related pressure injuries within 8-11 days. The results showed that endotracheal tube (61.4%), non-invasive ventilation/oxygen mask (52.6%), Foley catheter (49.1%), and nasogastric tube (36.8%) devices were the most common causes of the development of medical device-related pressure injuries. Patients' demographic characteristics were found to have a significant effect on the development of medical device-related pressure injuries (p < .05).
CONCLUSION
The study found that the incidence of medical device-related pressure injuries was relatively high and that a relationship was observed between the patients' demographic characteristics and medical device-related pressure injuries. It is crucial that ICU nurses, who are more likely to encounter medical device-related pressure injuries, consider these factors when caring for their patients and take appropriate preventive measures to reduce the incidence of these injuries.
Topics: Humans; Pressure Ulcer; Cross-Sectional Studies; Male; Female; Incidence; Middle Aged; Adult; Intensive Care Units; Aged; Equipment and Supplies; Risk Factors
PubMed: 38365519
DOI: 10.1016/j.jtv.2024.02.007 -
Infection Apr 2024Cardiac implantable electronic devices (CIED) are increasingly used worldwide, and infection of these devices remains one of the most feared complications.CIED... (Review)
Review
Cardiac implantable electronic devices (CIED) are increasingly used worldwide, and infection of these devices remains one of the most feared complications.CIED infections (CDIs) represent a challenge for physicians and the healthcare system in general as they require prolonged hospitalization and antibiotic treatment and are burdened by high mortality and high costs, so management of CDIs must be multidisciplinary.The exact incidence of CDIs is difficult to define, considering that it is influenced by various factors mainly represented by the implanted device and the type of procedure. Risk factors for CDIs could be divided into three categories: device related, patient related, and procedural related and the etiology is mainly sustained by Gram-positive bacteria; however, other etiologies cannot be underestimated. As a matter of fact, the two cornerstones in the treatment of these infections are device removal and antimicrobial treatment. Finally, therapeutic drug monitoring and PK/PD correlations should be encouraged in all patients with CDIs receiving antibiotic therapy and may result in a better clinical outcome and a reduction in antibiotic resistance and economic costs.In this narrative review, we look at what is new in the management of these difficult-to-treat infections.
Topics: Humans; Pacemaker, Artificial; Defibrillators, Implantable; Device Removal; Anti-Bacterial Agents; Heart Diseases; Communicable Diseases; Prosthesis-Related Infections
PubMed: 37996646
DOI: 10.1007/s15010-023-02130-8 -
European Heart Journal. Cardiovascular... Dec 2023More than 500 000 cardiovascular implantable electronic devices (CIEDs) are implanted in the European Society of Cardiology countries each year. The role of...
Imaging in patients with cardiovascular implantable electronic devices: part 1-imaging before and during device implantation. A clinical consensus statement of the European Association of Cardiovascular Imaging (EACVI) and the European Heart Rhythm Association (EHRA) of the ESC.
More than 500 000 cardiovascular implantable electronic devices (CIEDs) are implanted in the European Society of Cardiology countries each year. The role of cardiovascular imaging in patients being considered for CIED is distinctly different from imaging in CIED recipients. In the former group, imaging can help identify specific or potentially reversible causes of heart block, the underlying tissue characteristics associated with malignant arrhythmias, and the mechanical consequences of conduction delays and can also aid challenging lead placements. On the other hand, cardiovascular imaging is required in CIED recipients for standard indications and to assess the response to device implantation, to diagnose immediate and delayed complications after implantation, and to guide device optimization. The present clinical consensus statement (Part 1) from the European Association of Cardiovascular Imaging, in collaboration with the European Heart Rhythm Association, provides comprehensive, up-to-date, and evidence-based guidance to cardiologists, cardiac imagers, and pacing specialists regarding the use of imaging in patients undergoing implantation of conventional pacemakers, cardioverter defibrillators, and resynchronization therapy devices. The document summarizes the existing evidence regarding the use of imaging in patient selection and during the implantation procedure and also underlines gaps in evidence in the field. The role of imaging after CIED implantation is discussed in the second document (Part 2).
Topics: Humans; Defibrillators, Implantable; Arrhythmias, Cardiac; Electric Countershock; Heart; Cardiovascular System; Pacemaker, Artificial
PubMed: 37861372
DOI: 10.1093/ehjci/jead272 -
Journal of Clinical Neurophysiology :... Mar 2024Electroencephalography (EEG) monitoring has served as a cornerstone in the diagnostic and therapeutic evaluation of epilepsy since its development. This has been... (Review)
Review
Electroencephalography (EEG) monitoring has served as a cornerstone in the diagnostic and therapeutic evaluation of epilepsy since its development. This has been accomplished with short-term inpatient video-EEG hospitalization enabling observation of both the semiological and the electrographic features of seizures or with short-term home ambulatory EEG or video-EEG. The advantages of inpatient video-EEG monitoring are limited by high cost, inconvenience, and inability to monitor patients for long periods (weeks or months) as might be done in the outpatient setting. This limitation has impelled the development of wearable EEG devices, which aim to capture high-quality long-term EEG data in a user-friendly and unobtrusive manner. This review article aims to summarize three broad categories of wearable EEG devices, including scalp, subcutaneous, and intracranial EEG. In this review, we will discuss the features of each type of device and the implications for the management of epilepsy. This review does not aim to describe every wearable EEG device on the market but instead seeks to provide a broad overview of the various categories of device that are available, giving examples of each and those in development (with no intention to recommend or advocate for any particular product).
Topics: Humans; Prostheses and Implants; Electrocorticography; Wearable Electronic Devices; Epilepsy; Electroencephalography
PubMed: 38436387
DOI: 10.1097/WNP.0000000000001014 -
Perfusion Jul 2023The ProtekDuo, single site dual lumen cannula can be used in a multitude of configurations. In the medical literature, the ProtekDuo is described as right ventricular... (Review)
Review
The ProtekDuo, single site dual lumen cannula can be used in a multitude of configurations. In the medical literature, the ProtekDuo is described as right ventricular assist device (RVAD), as left ventricular assist device (LVAD), as biventricular assist device (BiVAD) when combined with an Impella device or other LVAD's, as double lumen drainage cannula on cardiopulmonary bypass (CPB), as RVAD with oxygenator, in veno-pulmonary (V-P) ECMO configuration, venovenous-pulmonary (VV-P) ECMO configuration with additional drainage cannula, and in veno-venopulmonary (V-VP) ECMO configuration as double lumen return cannula. Improvements in flow and oxygenation have been recognized in various settings and need further scientific evaluation. We summarized the above-mentioned configurations, technical aspects, and the present literature available for the ProtekDuo.
Topics: Humans; Extracorporeal Membrane Oxygenation; Heart-Assist Devices; Cannula; Cardiopulmonary Bypass; Oxygenators; Heart Failure
PubMed: 35619541
DOI: 10.1177/02676591221090607