Expert Review of Medical Devices最新文献

Objectives: Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval.

Methods: Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 μg/mm²) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE).

Results: Fifty-two subjects were enrolled, 69% men, median age 69 (49-83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (-0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively.

Conclusion: The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.

Background: Airway management in life-threatening emergencies is essential for children, and endotracheal intubation is the gold standard. It protects against regurgitation and enables mechanical ventilation. New types of airway management equipment are being developed and implemented to meet the needs of medical personnel.

Research design and methods: This prospective, randomized, cross-over simulation trial evaluated the success of endotracheal intubation in three scenarios: normal airway (scenario-A), tongue edema (scenario-B), and continuous chest compression (scenario-C), using the bébé Vie Scope™ laryngoscope (VieScope) and the Macintosh blade laryngoscope (MAC) as a comparative tool performed by nurses with limited tracheal intubation experience.

Results: The results of the study showed that in scenario-A, there were no significant differences in the first attempt success rate or endotracheal intubation time between VieScope and MAC. However, VieScope was associated with better visualization of the glottis. In scenarios B and C, VieScope was significantly more effective than MAC in terms of first-pass success rate, time to intubate, Cormack-Lehane grade, POGO score, and ease of endotracheal intubation.

Conclusions: Bébé VieScope may be useful for endotracheal intubation in pediatric patients, particularly in cases of tongue edema and ongoing chest compression, providing a higher first-pass success rate than conventional laryngoscopes.

Introduction: Fecal incontinence is a common chronic disease, which not only brings inconvenience to the lives of patients, but also causes great psychological harm to patients. Artificial anal sphincter is an innovative method that may treat fecal incontinence, and now has been clinically applied.

Areas covered: This article will review recent developments in mechanisms and clinical applications of artificial anal sphincter. The current results of clinical trials show that the implantation of artificial sphincter will cause morphological changes of surrounding tissues, and related biomechanical imbalance will lead to the loss of effectiveness of the device and various complications. In terms of safety, postoperative patients suffer from various complications such as infection, corrosion, tissue ischemia, mechanical failure, and difficulty in emptying. In terms of effectiveness, there is currently no long-term research data to prove that the implanted device can maintain a long-term functional state.

Expert opinion: The key issue for the safety and effectiveness of implantable devices is the biomechanical compatibility of implantable devices was proposed. Based on the superelasticity of shape memory alloy, this article proposes a new type of constant force artificial sphincter device, which provides a new direction for solving the clinical application of artificial anal sphincter.

Background: Due to the increasing use of contact lenses (CL) and the interest in ocular and body size relationships, this study aimed to compare measurements from two biometers (contact ultrasonic EchoScan US-800 and non-contact optical Lenstar LS900) with and without CL and to explore the relationship between ocular and body biometric parameters.

Design and methods: This cross-sectional study measured ocular biometry using two biometers along with their body height and right foot length in 50 participants. Differences between biometry data from the two devices were compared and correlations between ocular and body biometric values were analyzed.

Results: All parameters showed interbiometric differences (p ≤ 0.030), except crystalline lens thickness during CL wear (p = 0.159). Comparing measurements with and without CL, differences were observed in axial length (p < 0.001), vitreous length measured by optical biometer (p = 0.016), and anterior chamber depth by ultrasonic biometer (p < 0.016). Lens thickness remained unaffected (p ≥ 0.190). Body height and foot length were correlated with anterior chamber depth, vitreous length, and axial length (p ≤ 0.019, r ≥ 0.330). Most biometric parameters were correlated among them using both devices (p ≤ 0.037, r ≥ 0.296).

Conclusions: These biometers are not interchangeable and CL affects measurements. Body height and foot length correlate with ocular dimensions, and most ocular biometric values correlate positively.

Introduction: Atrial fibrillation (AF) ablation is being performed more frequently and more widely at more centers. This stems from several factors including 1) demographic forces leading to an increased prevalence of the arrhythmia; 2) greater availability of ambulatory monitoring making diagnosis more frequent; 3) relative inefficacy of medications; and 4) improved safety and efficacy of the procedure. Ablation has become much more streamlined and reproducible than a decade ago, but life-threatening complications may still arise.

Areas covered: This review will focus on awareness, avoidance, and early recognition and management of complications of AF ablation. This literature review is challenged by differing approaches to ablation of AF both within a center and between centers, the rapid improvement of technology making the outcomes associated with a therapeutic strategy begun a few years prior relatively obsolete, as well as the heterogeneity of the population being studied.

Expert opinion: Newer technologies are on the horizon which will allow us to ablate AF with increasing efficacy, efficiency, and hopefully safety. Such new technology and changing usage mandate vigilance to avoid complications.

Introduction: A key determinant of prosthesis use is the quality of fit of the prosthetic socket. The socket surrounds the residual limb and applies the appropriate force distribution to the soft tissues to maintain suspension, support, and stabilization as well as translate limb movement to prosthesis movement. The challenge in socket fabrication lays in achieving geometry that provides the appropriate force distribution at physiologically appropriate locations; a task dependent on the understanding of interface tissue-mechanics.

Areas covered: In the last 20 years substantial advancements in sensor innovation and computational power have allowed researchers to quantify the socket-residual limb interface; this paper reviews prominent measurement and sensing techniques described in literature over this time frame. Advantages and short comings of each technique are discussed with a focus on translation to clinical environments.

Expert opinion: Prosthetic sockets directly influence comfort, device use, user satisfaction, and tissue health. Advancements in instrumentation technology have unlocked the possibility of sophisticated measurement systems providing quantitative data that may work in tandem with a clinician's heuristic expertise during socket fabrication. If validated, many of the emerging sensing technologies could be implemented into a clinical setting to better characterize how patients interact with their device and help inform prosthesis fabrication and assessment techniques.

Introduction: The Evoke® spinal cord stimulation (SCS) device enables the closed-loop feedback of dynamically measured evoked compound action potentials (ECAPs) to adjust stimulation amplitude for every stimulation pulse to maintain the stimulation output level near a targeted ECAP amplitude. No other commercially available SCS device presently uses physiologic feedback from the spinal cord to adjust stimulation. Clinicians should be familiar with the differences in devices and with the latest technologies to provide optimized patient care.

Areas covered: In this device profile, the Evoke system is described and the system capabilities are differentiated from other available SCS devices. A systematic review was conducted based on best practice guidance to identify all available evidence on the safety and efficacy of the Evoke SCS system.

Expert opinion: The Evoke SCS system offers unique capabilities as a means to optimize therapy delivery tailored to each individual patient. Data through 24-months follow-up show statistically significant, clinically meaningful, ample, consistent, and strong evidence of the safety and efficacy of the Evoke system for the treatment of chronic intractable pain.

Introduction: Peripheral nerve stimulation has been demonstrated as a viable alternative to sacral nerve stimulation in managing refractory overactive bladder (OAB). New technologies allow the internalization of tibial nerve stimulators through various apparatuses. One such device, the eCoin, is a small, coin-shaped device that can be implanted adjacent to the tibial nerve that provides pre-programmed stimulation.

Areas covered: We will review the literature on eCoin implantation, from proof of concept to mid-term data, with the longest period of follow-up being 12 months. All studies on this technology will be reviewed, along with an analysis of the current state of play in implantable neuromodulators for overactive bladder. Efficacy, durability, adverse events, and viability of eCoin as a long-term management option will be considered.

Expert opinion: The eCoin device demonstrates promising early data for efficacy in managing overactive bladder symptoms. Complication rates remain low and are mostly related to wound healing following the initial placement of the device. Research into the continued improvement and modification of the device appears optimistic, but longer-term data still need to be obtained. Indeed, implantable PTNS have a role in the future management of overactive bladder, and devices such as eCoin will still need to prove a long-term benefit to be a mainstay of management.

Background: For patients with lower pole renal calculi (LPC), preoperative evaluation of infundibulopelvic angles (IPA) is of great significance; however, conventional measuring method is often inconvenient in clinical setting. Here we introduce a rapid novel method using built-in inclinometer in smartphone which is often used in anatomical parameters evaluating to implement the measurement of IPA.

Materials and methods: The randomized, self-controlled study on evaluating inclinometer application measured IPA on urography films collected from enrolled LPC patients. Results of statistical analysis for its validity and reliability compared to conventional PACS system are reported. Predictive performance of postoperative stone-free rates by IPA measured with the novel method was also evaluated in this study.

Results: Bland-Altman plot result shows that there is favorable agreement between IPA values of these two methods. The time required to utilize the PACS was considerably greater than time required to take similar measure using smartphones. The precision-recall curve (PRC) indicates that the new method has similar predictive performance for postoperative clearance rates as PACS.

Conclusions: In summary, measurement of IPA implemented by integrated inclinometer of smartphone is rapid, convenient, accurate and reliable in evaluating renal anatomy parameters of LPC patients.

Introduction: Recent technologies and new devices continue to be developed in vitreoretinal surgeries, and they provide more details, enhance safety, improve surgeons' comfort, and better visual and anatomical outcomes. Some devices have been used for better visualization during surgery, and some help the operation performance. They are divided into the following titles: Intraoperative OCT (including hand-held, probe-integrated, and microscope-integrated OCT), three-dimensional visualization system, virtual reality system, endoscopic vitrectomy (fiber optics and non-fiber optics), wide-angle viewing systems (contact and non-contact lenses), endo-illumination, light filters, chromovitrectomy, the retinal prosthesis (including epiretinal, subretinal, and suprachoroidal devices), robot-assisted vitreoretinal surgery, newer Vitreoretinal instruments, gene and cell therapy.

Areas covered: In this narrative review, we focused on PubMed articles between 2010-2023 with these keywords: 'Optical Coherence Tomography,' 'Three-Dimensional,' 'Virtual System,' 'intraoperative,' 'endoscopic,' 'vitrectomy,' 'lens,' 'illumination,' 'filters,' 'chromovitrectomy,' 'prosthesis,' 'robotic surgery,' 'instrument,' 'gene,' 'cell.'

Expert opinion: The main aim of this review is to update the reader on the latest progression in intraoperative imaging and surgical vision technologies and to provide an understanding of how each has helped improve operation and surgical outcomes. The surgeons should know recent updates to do their best and achieve the most excellent results.