Clips for managing perforation and bleeding after colorectal endoscopic mucosal resection.
Authors: Turan AS, Ultee G, Van Geenen EJM, Siersema PD Abstract INTRODUCTION: The most commonly used treatment for advanced colorectal adenomas is endoscopic mucosal resection (EMR). The increased number of EMRs since the introduction of the screening program for colorectal cancer has resulted in an increase in EMR-related complications. This review summarizes the current knowledge for the use of clips for the treatment and prevention of complications after EMR. Areas covered: The historical development of clips is summarized and their properties are evaluated. An overview is presented of the evidence for therapeu...
Source: Expert Review of Medical Devices - May 23, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Uses and potential for cardiac magnetic resonance imaging in patients with cardiac resynchronisation pacemakers.
Authors: Koshy A, Witte K Abstract INTRODUCTION: Cardiac magnetic resonance (CMR) imaging has been shown to be safe as an imaging modality for patients with cardiac resynchronisation (CRT) devices. As a widely accepted method of measuring cardiac volumes, mass and ejection fraction, CMR has become a core part of the diagnostic panel. A number of studies have already highlighted a role in optimising left ventricular lead placemen with evidence that scanning is useful prior to implantation to predict outcomes and optimising device effect. By balancing the considerations of CMR with the benefits, there may be further ...
Source: Expert Review of Medical Devices - May 19, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Patient perspectives on benefits and risks of implantable interfaces for upper limb prostheses: a national survey.
Authors: Resnik L, Benz H, Borgia M, Clark MA Abstract OBJECTIVE: Patient perspectives on benefits and risks of implantable interfaces for prostheses are needed. METHODS: A telephone survey was administered to 808 Veterans. Multivariate logistic regression identified factors associated with willingness to consider surgery to restore touch and better movement control. Risk and benefit ratings were compared. RESULTS: 41.8% of unilateral and 40.6% of bilateral amputees were willing to consider surgery for touch; 49.0% were willing to consider surgery for control. Persons 65-75 years and>75 were 0.42 (p=0.00...
Source: Expert Review of Medical Devices - May 17, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Top 100 cited noninvasive neuromodulation clinical trials.
Authors: Lucena MFG, Teixeira PEP, Bonin Pinto C, Fregni F Abstract INTRODUCTION: Transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) are noninvasive neuromodulation techniques used as therapeutic and research tools for several neuropsychiatric conditions. Given the exponential scientific growth of this field we aimed to systematically review the most cited clinical trials using TMS or tDCS. Areas covered: A de-novo keyword search strategy identified and characterized the 100 most-cited trials. Total citation count for the most cited trials was 13,204. Articles were published ...
Source: Expert Review of Medical Devices - May 17, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Predictive validity of automated oscillometric blood pressure monitors for screening atrial fibrillation: a systematic review and meta-analysis.
This study was conducted to verify if automated oscillometric blood pressure monitors (AOBPMs) have sufficiently high predictive validity to screen patients with atrial fibrillation (AF). METHODS: Electronic searches were performed to identify all studies published between 1946 and July 14, 2018, from indexed in Ovid-Medline, Embase, the Cochrane Library and CINAHL by using the following keywords: "atrial fibrillation," "atrial flutter," "blood pressure monitor," and "sphygmomanometer." RESULTS: Thirteen diagnostic accuracy studies, including a total of 9,380 elderly, were in...
Source: Expert Review of Medical Devices - May 17, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Cybersecurity in cardiac implantable electronic devices.
Authors: Martignani C Abstract INTRODUCTION: Cardiac implantable electronic devices (CIEDs) integrate numerous automatic and monitor functions. Nowadays, most CIEDs are connected to the Internet (via Wi-Fi, Bluetooth or smartphone) to ensure remote monitoring of technical and clinical data: despite the importance of such a monitoring, especially from a clinical point of view, concerns have been raised about information (IT) security in terms of both privacy and security for CIEDs' carriers. Areas covered: This review will provide an outline of remote monitoring of CIEDs, main IT security issues that have affected t...
Source: Expert Review of Medical Devices - May 10, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Localization strategies for robotic endoscopic capsules: a review.
Authors: Bianchi F, Masaracchia A, Shojaei Barjuei E, Menciassi A, Arezzo A, Koulaouzidis A, Stoyanov D, Dario P, Ciuti G Abstract INTRODUCTION: Nowadays, mass screening campaigns for colorectal cancer diagnosis in the early and curable stage is essential yet limited due to many reasons, for example, invasiveness, fear of pain, and embarrassment for patients. Indeed, mass screening programs, allowing precancerous lesion detection, are the most cost-effective way to reduce mortality and potentially eradicate colorectal cancer threat. Accurate localization represents a key element in capsule endoscopy, that is, estim...
Source: Expert Review of Medical Devices - May 7, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Polyhydroxyalkanoate (PHA): applications in drug delivery and tissue engineering.
Authors: Elmowafy E, Abdal-Hay A, Skouras A, Tiboni M, Casettari L, Guarino V Abstract INTRODUCTION: The applications of naturally obtained polymers are tremendously increased due to them being biocompatible, biodegradable, environmentally friendly and renewable in nature. Among them, polyhydroxyalkanoates are widely studied and the can be utilized in many areas of human life research such as drug delivery, tissue engineering, and other medical applications. Areas Covered: This review provides an overview of the polyhydroxyalkanoates biosynthesis and their possible application in drug delivery in the range of micro...
Source: Expert Review of Medical Devices - May 7, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Endoscopic transforaminal lumbar interbody fusion: a comprehensive review.
Authors: Ahn Y, Youn MS, Heo DH Abstract INTRODUCTION: Endoscopic spine surgery has been developed as a minimally invasive technique for decompression in patients with lumbar disc herniation or lumbar stenosis. Recent reports have described the use of endoscopic technology in lumbar fusion surgeries, especially for transforaminal lumbar interbody fusion (TLIF). This review aimed to summarize the current techniques of endoscopic TLIF and to discuss the benefits, limitations, and future perspectives of endoscopic lumbar fusion surgery. Areas covered: This review covered the English-language medical literature publish...
Source: Expert Review of Medical Devices - May 4, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Update on the management and associated challenges of adult patients treated with veno-arterial extracorporeal membrane oxygenation.
This article aims to provide a review and evaluation of strategies reported in the literature to wean patients from VA ECMO, with a special emphasis on weaning protocols. A selected successful weaning protocol and rate of removal of adult patients from VA ECMO from recent reports will be also discussed. Expert commentary: To improve patient outcome, it is essential to remove patients from VA ECMO without weaning failure. Furthermore, the accurate evaluation of the patient's condition must be principal. However, as technology advances, the strategy of weaning patients from VA ECMO or drug therapies is changing, and we must ...
Source: Expert Review of Medical Devices - May 4, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

A clarion call for understanding regulatory processes for additive manufacturing in the health sector.
Authors: Horst A, McDonald F, Hutmacher DW Abstract INTRODUCTION: As Additive Manufacturing (AM) in the health sector evolves to the point where products can be translated into the clinic, these manufactured goods need to be assessed by regulators in order for such products to be manufactured, sold, and used in accordance with the law. In this article, the authors argue that if AM products in the health sector are to be regulated in the near future, stakeholders involved in translational research need to understand the challenges faced by both regulators and industry. We portray different points of possible dissona...
Source: Expert Review of Medical Devices - May 2, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Total hip arthroplasty in the setting of tuberculosis infection of the hip: a systematic analysis of the current evidence.
Authors: Sultan AA, Dalton SE, Umpierrez E, Samuel LT, Rose E, Tamer P, Rabin JM, Mont MA Abstract INTRODUCTION: Total hip arthroplasty (THA) is a viable option to restore mobility and relieve pain in patients with severe post-tuberculous arthritis, but has been controversial due to concerns of disease reactivation. Over the past several decades, a number of authors have reported outcomes of THA for tuberculosis (TB) infections. However, there is marked heterogeneity in regard to disease activity, surgical approaches, and the use of chemoprophylaxis in these studies. Areas covered: The purpose of this review was to...
Source: Expert Review of Medical Devices - April 23, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Three-year outcome of everolimus-eluting bioresorbable vascular scaffold versus everolimus-eluting metallic stents: a comprehensive updated meta-analysis of randomized controlled trials.
CONCLUSIONS: The results of our study showed no inferiority of EE-BRS regarding TVF, DOCE, POCE and ID-TLR, 1-year and 2-years after interventions, but an enhanced risk of thrombosis in EE-BRS patients, which was no longer apparent in the 3-year follow-ups. PMID: 31008654 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - April 23, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure: a single-center experience (LAAC combined PFO/ASD closure).
Authors: Yu J, Liu X, Zhou J, Xue X, Muenzel M, Schulze PC, Moebius-Winkler S, Keil T, Meng Z, Tang S Abstract OBJECTIVES: To report long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure. METHODS: A retrospective study of 370 consecutive patients undergoing LAAC procedures using the Watchman (WM) device. Data were compared between 330 cases only with LAAC procedure (Group I) and 25/5 (PFO/ASD) cases with sequential procedures of LAAC and PFO/ASD closure (Group II). RESULTS: Compared to Group I, Group II had more males (86.7% vs. 65.8%, p
Source: Expert Review of Medical Devices - April 20, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Artificial Intelligence (AI) for the early detection of breast cancer: a scoping review to assess AI's potential in breast screening practice.
Authors: Houssami N, Kirkpatrick-Jones G, Noguchi N, Lee CI Abstract INTRODUCTION: Various factors are driving interest in the application of artificial intelligence (AI) for breast cancer (BC) detection, but it is unclear whether the evidence warrants large-scale use in population-based screening. Areas covered: We performed a scoping review, a structured evidence synthesis describing a broad research field, to summarise knowledge on AI evaluated for BC detection and to assess AI's readiness for adoption in BC screening. Studies were predominantly small retrospective studies based on highly selected image datasets...
Source: Expert Review of Medical Devices - April 20, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Recent advances in PET probes for hepatocellular carcinoma characterization.
Authors: Filippi L, Schillaci O, Bagni O Abstract INTRODUCTION: Positron Emission Tomography (PET) with 18F-fluorodeoxyglucose (FDG) presents some limitations for imaging of hepatocellular carcinoma (HCC), the most common primary hepatic malignancy. Areas covered: The authors discuss the accuracy and limitations of FDG for HCC detection. Then, authors examine the recent advances in PET tracers other than FDG for the biological and prognostic characterization of HCC such as 11C-acetate, 11C-choline and its 18F-labeled derivatives. Expert commentary: FDG PET can be helpful for the identification of the more aggressiv...
Source: Expert Review of Medical Devices - April 17, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Bioburden and transmission of pathogenic bacteria through elevator channel during endoscopic retrograde cholangiopancreatography: application of multiple-locus variable-number tandem-repeat analysis for characterization of clonal strains.
CONCLUSION: Identity of P. aeruginosa strains among the bile and elevator channel samples showed possibility of cross-contamination among patients even at distinct time intervals. PMID: 30957585 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - April 10, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Recent advances in microcatheter technology for the treatment of chronic total occlusions.
Authors: Vemmou E, Nikolakopoulos I, Xenogiannis I, Megaly M, Hall A, Wang Y, Chavez I, Garcia S, Burke MN, Brilakis ES Abstract INTRODUCTION: Use of a microcatheter is essential for chronic total occlusion (CTO) percutaneous coronary intervention (PCI). Several microcatheters have recently been introduced in clinical practice aiming to improve deliverability and resistance to deformation. Areas covered: We review the technical characteristics of several new microcatheters (Mamba, Mamba Flex, Teleport Control, Teleport, Nhancer Rx, Sasuke, and ReCross) and compare them with existing microcatheters. Expert Opinion: ...
Source: Expert Review of Medical Devices - April 3, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Remote-controlled internal lengthening plate for distraction osteogenesis in pediatric patients.
CONCLUSIONS: This device represents a major advancement in the field of pediatric limb-lengthening, addressing a demographic gap left open by current implantable devices. PMID: 30931640 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - April 3, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Treatment for lumbar spinal stenosis in elderly patients using percutaneous endoscopic lumbar discectomy combined with postoperative three-dimensional traction.
CONCLUSION: PELD combined with postoperative three-dimensional traction reduced hospital stay, provided adequate decompression for the spine, and also improved surgical outcomes. PMID: 30916589 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - March 28, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Device Solutions for a Challenging Spine Surgery: Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF).
Authors: Sayari AJ, Patel DV, Yoo JS, Singh K Abstract INTRODUCTION: Lumbar interbody fusion remains a mainstay in the treatment of degenerative spinal pathology. Interbody devices are often used in an attempt to improve fusion rates and outcomes. Minimally invasive techniques lend unique advantages, but are challenging and often plagued with complications. Specifically, minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) has a steep learning curve and there is a lack of concise information on solutions to optimize outcomes. Areas Covered: This review details an appropriate surgical technique of MI...
Source: Expert Review of Medical Devices - March 28, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The Mobi-C ® cervical disc and other devices for two-level disc replacement: overview of its safety and efficacy.
The Mobi-C® cervical disc and other devices for two-level disc replacement: overview of its safety and efficacy. Expert Rev Med Devices. 2019 Mar 25;:1-9 Authors: Badve SA, Kurra S, Nunley PD, Lavelle WF Abstract INTRODUCTION: Cervical disc arthroplasty (CDA) has become an acceptable alternative for anterior cervical discectomy and fusion (ACDF) for a significant patient population with cervical radiculopathy and/or myelopathy secondary to degenerative changes in the cervical spine. There are sufficient mid- and long-term data supporting performance and safety of one-level CDA. With the success of ...
Source: Expert Review of Medical Devices - March 27, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

An update on: Long-term outcomes of penile prostheses for the treatment of erectile dysfunction.
Authors: Dick B, Tsambarlis P, Reddy A, Hellstrom WJ Abstract INTRODUCTION: Penile prosthesis placement is the gold standard for the treatment of erectile dysfunction (ED) refractory to medical therapy; however, limited data exists on the long-term outcomes of these devices. Areas Covered: A PubMed search focused on long-term outcomes of penile prosthetics was performed. Studies with a follow-up of less than 5 years were excluded. Included studies were arranged chronologically by implant date to identify trends in device lifetime. Data was further scrutinized to separate device failure secondary to mechanical malfu...
Source: Expert Review of Medical Devices - March 24, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Is there a role for ultrasonic surgery in transoral laryngeal cancer resections?
Authors: Tirelli G, Gardenal N, Gatto A, Bonini P, Tofanelli M, Fernández-Fernández MM Abstract INTRODUCTION: Minimally-invasive surgery for laryngeal cancer is nowadays the goal of all larynx surgeons. Transoral laser microsurgery is a widespread and standardized technique that has made it possible to reduce surgical morbidities, hospitalization and to spare laryngeal function. Nonetheless, it has some limitations, which may be exceeded by using new optical and cutting devices as in TransOral UltraSonic Surgery. Areas Covered: The aim of this paper is to identify current knowledge about Ultrasonic Sc...
Source: Expert Review of Medical Devices - March 21, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Surgical drilling of curved holes in bone - a patent review.
Authors: Sendrowicz A, Scali M, Culmone C, Breedveld P Abstract INTRODUCTION: Conventional surgical drills are rigid straight instruments used to make holes in bones. They lack the ability to follow a curved pathway, making them impractical for several surgical procedures. For this reason, there is a continuous need for improved devices for surgical drilling of curved holes. Areas Covered: This review provides a comprehensive overview and classification of the patent literature of surgical drills able to produce a curved hole. The goal is to identify the fundamental mechanical designs of the drills. The medical sec...
Source: Expert Review of Medical Devices - March 21, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Polymeric middle ear prosthesis enriched with silver nanoparticles - first clinical results.
CONCLUSIONS: Results confirm the bactericidal efficacy and hearing improvement of the Otoimplant. PMID: 30884249 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - March 20, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

An update on intrasaccular flow disruption for the treatment of intracranial aneurysms.
We describe the principal concept and the technical evolution of intrasaccular flow disruption and discuss all devices that have to date been presented, with a special focus on the WEB. Key results of the literature are summarized, and we review possible future indications for this innovative treatment concept. Expert commentary: The tools for the endovascular management of intracranial aneurysms continue to evolve rapidly with intrasaccular flow disruption being the most recent innovation in the field. The WEB is currently the only device on the market. Compared to competing techniques, intrasaccular flow disruption offer...
Source: Expert Review of Medical Devices - February 20, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Recent advancements in the minimally invasive management of esophageal perforation, leaks and fistulae.
Authors: Siddiqi S, Schraufnagel D, Siddiqui HU, Javorski MJ, Mace A, El-Naggar A, Elgharably H, Vargo PR, Steffen R, Hasan SM, Raja S Abstract INTRODUCTION: Historically, the gold standard management of esophageal perforations, leaks, and fistulae has been traditional open surgery but it is associated with significant morbidity and mortality. Minimally invasive approaches offer alternatives to surgery in treating hemodynamically stable patients with such defects. In this review article, we will discuss the recent advancements in the minimally invasive management of esophageal perforations, leaks, and fistulas. Are...
Source: Expert Review of Medical Devices - February 17, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The effectiveness of Hemopatch ™ in preventing postoperative distal pancreatectomy fistulas.
The effectiveness of Hemopatch™ in preventing postoperative distal pancreatectomy fistulas. Expert Rev Med Devices. 2019 Feb 13;: Authors: Pisapia A, Crolla E, Saracco M, Saglioccolo A, Dolce P, Molino C Abstract OBJECTIVES: Post-operative fistula after distal pancreatectomy (DP) is still a significant complication, although many tools and tips have been utilized to try to reduce its elevated frequency. This paper focuses on the role of a sealing hemostatic device, Hemopatch™, to prevent postoperative pancreatic fistula (POPF) after DP. METHODS: Retrospectively we divided our sampling o...
Source: Expert Review of Medical Devices - February 15, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The Angel catheter for the prevention of pulmonary embolism: combining an IVC filter and a triple-lumen central venous catheter.
Authors: Achaibar K, Waldmann C, Taccone FS Abstract INTRODUCTION: Pulmonary embolism is common in critical care patients and carries significant morbidity and mortality. Concurrent risk of severe bleeding in this population may prohibit anticoagulation. Areas covered: The Angel Catheter device is a central venous catheter combined with an inferior vena cava filter inserted at the bedside for pulmonary embolism prevention. Our review examines the role of this device, safety, efficacy and the limitations it presents. Expert opinion: We conclude the Angel catheter should be considered in critical care patients with s...
Source: Expert Review of Medical Devices - February 15, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Amplatzer Patent Foramen Ovale Occluder: Safety and Efficacy.
Authors: Madhkour R, Wahl A, Praz F, Meier B Abstract INTRODUCTION: The patent foramen ovale (PFO) is a common anatomical variant in humans (prevalence 25%). Most often asymptomatic, it may engender paradoxically embolic strokes, myocardial infarctions, or visceral or peripheral ischemia. It is causatively related to migraine, positional or exertional hypoxemia with dyspnea, diving incidents, high altitude edema, and sleep apnea. Percutaneous closure of atrial septal defects was first performed in the seventies. A dedicated PFO occluder (Amplatzer PFO Occluder) was first used on September 10, 1997 by Kurt Amplatz a...
Source: Expert Review of Medical Devices - February 12, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Braided stents and their impact in intracranial aneurysm treatment for distal locations: from flow diverters to low profile stents.
Authors: Iosif C, Biondi A Abstract INTRODUCTION: Intracranial aneurysms in distal locations are sometimes difficult to treat due to their branching locations and the presence of blister-like or very wide-necked aneurysms. Braided intracranial stents, including flow diverters (FDs) and low-profile braided intracranial stents (LPBSs) may provide additional advantages, due to their flow-diverting properties. Areas covered: The use of FDs in off-label, distal intracranial locations has been increasing with promising outcomes and has given rise to the LPBS, which has less flow-diverting properties, allowing for easier ...
Source: Expert Review of Medical Devices - January 29, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Mechanical properties and performances of contemporary drug-eluting stent: focus on the metallic backbone.
Authors: Chichareon P, Katagiri Y, Asano T, Takahashi K, Kogame N, Modolo R, Tenekecioglu E, Chang CC, Tomaniak M, Kukreja N, Wykrzykowska JJ, Piek JJ, Serruys PW, Onuma Y Abstract INTRODUCTION: Drug-eluting stents (DES) are still the standard of care in percutaneous coronary intervention (PCI) since the fall of bioresorbable scaffolds with respect to safety. The unbeatable advantage of a metallic stent when compared with a scaffold is a stronger mechanical property and more sustainable vascular support. Recent development of contemporary metallic stent has focused on the reduction of strut thickness. However, ther...
Source: Expert Review of Medical Devices - January 26, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Rehabilitative devices for a top-down approach.
Authors: Morone G, Spitoni GF, de Bartolo D, Ghanbari Ghooshchy S, Di Iulio F, Paolucci S, Zoccolotti P, Iosa M Abstract INTRODUCTION: In recent years, neurorehabilitation has moved from a "bottom-up" to a "top down" approach. This change has also involved the technological devices developed for motor and cognitive rehabilitation. It implies that during a task or during therapeutic exercises, new "top-down" approaches are being used to stimulate the brain in a more direct way to elicit plasticity-mediated motor re-learning. This is opposed to "Bottom up" approaches, which act...
Source: Expert Review of Medical Devices - January 26, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Prostheses for reverse total shoulder arthroplasty.
Authors: Kazley JM, Cole KP, Desai KJ, Zonshayn S, Morse AS, Banerjee S Abstract INTRODUCTION: Historically, patients with rotator cuff arthropathy had limited reconstructive options. The early generations of reverse total shoulder arthroplasty (rTSA) designs had increased failure rates due to loosening of glenoid baseplates secondary to excessive torques. In 1985, Paul Grammont introduced a prosthetic design changing the center of rotation that addressed this major complication. The Grammont principles remain the foundation of modern reverse total shoulder prostheses, although the original design has undergone sev...
Source: Expert Review of Medical Devices - January 25, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Advanced methods of spinal stimulation in the treatment of chronic pain: pulse trains, waveforms, frequencies, targets and feedback loops.
Authors: Maheshwari A, Pope JE, Deer TR, Falowski S Abstract INTRODUCTION: Spinal cord stimulation has emerged as a state-of-the-art evidence based treatment for chronic neuropathic pain and mixed nociceptive-neuropathic pain. In recent years, several newer devices and treatment algorithms have provided unique and effective ways of treating chronic pain by spinal cord stimulation. In a previous review, the authors commented on the five-year forecast for high frequency and Burst wave forms, as the only two paresthesia independent SCS strategies. Over the last five years there has been considerable addition to the ou...
Source: Expert Review of Medical Devices - January 11, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

How prosthetic design influences knee kinematics: a narrative review of tibiofemoral kinematics of healthy and joint-replaced knees.
Authors: Meng F, Jaeger S, Sonntag R, Schroeder S, Smith-Romanski S, Kretzer JP Abstract INTRODUCTION: To improve the total knee arthroplasty (TKA) prosthesis design, it is essential to study the kinematics of the tibiofemoral joint. Many studies have been conducted in this area; however, conflicting results and incomparable testing methods make it difficult to draw definitive conclusions or compare research from studies. The goal of this article is to introduce what is known about both healthy and prosthetic tibiofemoral joint kinematics. Areas covered: Healthy tibiofemoral joint kinematics are reviewed in vivo by...
Source: Expert Review of Medical Devices - January 6, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Embracing simplexity: the role of artificial intelligence in peri-procedural medical safety.
Authors: Patriarca R, Falegnami A, Bilotta F PMID: 30602324 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - January 5, 2019 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Constructing artificial urinary conduits: current capabilities and future potential.
Authors: Adamowicz J, Van Breda SV, Klosnkowski T, Juszczak K, Pokrywczynska M, Drewa T Abstract INTRODUCTION: Intestinal segments are currently used in reconstructive urology to create urinary diversion after cystectomy. Ileal conduit (IC) is dominant type of urinary diversion. Nevertheless, IC isn't an ideal solution as the procedure still requires entero-enterostomy to restore the bowel continuity. This step is source of relevant complications that might prolong recovery time. Fabrication of artificial urinary conduit is tempting idea to introduce alternative form of urinary diversion which might improve cystect...
Source: Expert Review of Medical Devices - December 29, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Wearable sensors to improve detection of patient deterioration.
Authors: Joshi M, Ashrafian H, Aufegger L, Khan S, Arora S, Cooke G, Darzi A Abstract INTRODUCTION: Monitoring a patient's vital signs forms a basic component of care, enabling the identification of deteriorating patients and increasing the likelihood of improving patient outcomes. Several paper-based track and trigger warning scores have been developed to allow clinical evaluation of a patient and guidance on escalation protocols and frequency of monitoring. However, evidence suggests that patient deterioration on hospital wards is still missed, and that patients are still falling through the safety net. Wearable ...
Source: Expert Review of Medical Devices - December 26, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Suitability study of current endovascular aortic repair devices based on real-life anatomic data.
CONCLUSIONS: Any stent-graft with high suitability rates should be available off-the-shelf in any vascular department in order to cover the majority of cases. For challenging cases, special advantages of the stent-grafts should be taken under consideration. PMID: 30569766 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 22, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

A cost-effectiveness analysis of the use of safety-engineered syringes in reducing HBV, HCV, and HIV burden in Egypt.
CONCLUSION: Introducing SS in the Egyptian health care system might help in preventing transmission of blood borne infections that are acquired through health care settings. The overall benefit of investing in this technology is far more than CS. These findings encourage urgent adoption of SS by healthcare delivery institutions in similar resource-limited settings. PMID: 30571154 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 22, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Repeatability assessment of biometric measurements with different refractive states and age using a swept-source biometer.
CONCLUSIONS: IOLMaster 700 showed good repeatability for biometric and keratometric parameters in eyes classified according to their refractive error or age. PMID: 30560694 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 20, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Insertable cardiac monitors: current indications and devices.
Authors: Sakhi R, Theuns DAMJ, Szili-Torok T, Yap SC Abstract INTRODUCTION: Recurrent unexplained syncope is a well-established indication for an insertable cardiac monitor (ICM). Recently, the indications for an ICM has been expanded. Areas covered: This review article discusses the current indications for ICMs and gives an overview of the latest generation of commercially available ICMs. Expert commentary: The 2018 ESC Syncope guidelines have expanded the indications for an ICM to patients with inherited cardiomyopathy, inherited channelopathy, suspected unproven epilepsy, and unexplained falls. ICMs are also inc...
Source: Expert Review of Medical Devices - December 15, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

From the laboratory concept to clinical trials: the journey of Otoimplant so far.
This article describes a research path that medical device ought to negotiate before the clinical trials may start. PMID: 30523728 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 15, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Transcatheter aortic valve replacement: relative safety and efficacy of the procedure with different devices.
Authors: Del Val D, Ferreira-Neto AN, Asmarats L, Maes F, Guimaraes L, Junquera L, Wintzer J, Fischer Q, Barroso de Freitas Ferraz A, Puri R, Rodés-Cabau J Abstract INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is a well-established treatment for patients with severe aortic stenosis and intermediate-to-high surgical risk. The increasing clinical experience along with technical and design iterations of transcatheter valve systems have contributed to reducing adverse events and improving clinical outcomes. Areas covered: Overview of the latest generation transcatheter heart valves (THVs), focusin...
Source: Expert Review of Medical Devices - December 13, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Newer-generation of Edwards Transcatheter Aortic Valve Systems: SAPIEN 3, Centera and SAPIEN 3 Ultra.
Authors: Solomonica A, Choudhury T, Bagur R Abstract INTRODUCTION: Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe symptomatic aortic stenosis at moderate to high surgical risk. Newer devices are now available and broader indications are expected in the near future. Areas Covered: The Placement of Aortic Transcatheter Valves (PARTNER) trials initially proved the efficacy of TAVI with the Edwards SAPIEN balloon-expandable valve in patients deemed in-operable and at high-risk and later on in intermediate-risk patients using the SAPIEN-XT valve. These trials had ...
Source: Expert Review of Medical Devices - December 7, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Developing an optimized strategy with transcranial direct current stimulation to enhance the endogenous pain control system in fibromyalgia.
Authors: Duarte D, Castelo-Branco LEC, Uygur Kucukseymen E, Fregni F Abstract INTRODUCTION: Fibromyalgia affects more than 5 million people in the United States and has a detrimental impact on individuals' quality of life. Current pharmacological treatments provide limited benefits to relieve the pain of fibromyalgia, along with a risk of adverse effects; a scenario that explains the increasing interest for multimodal approaches. A tailored strategy to focus on this dysfunctional endogenous pain inhibitory system is transcranial direct current stimulation (tDCS) of the primary motor cortex. By combining tDCS with a...
Source: Expert Review of Medical Devices - December 7, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

A clinical update on the mid-term clinical performance of the Ovation endograft.
Authors: Koutsoumpelis A, Georgakarakos E, Tasopoulou KM, Kontopodis N, Argyriou C, Georgiadis GS Abstract INTRODUCTION: The Ovation stent-graft uncouples the steps of fixation and sealing via a pair of polymer-filled inflatable rings. Apart from the well-documented early results, newer data emerged for mid-term results of Ovation and are presented in this review. Areas covered: Aim of this article was to report all current studies with the mid-term results of the particular endograft, the incidence of complications and failure and discuss their management. Expert Commentary: The Ovation stent-graft exhibits very s...
Source: Expert Review of Medical Devices - December 7, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The Evolut R and Evolut PRO Transcatheter Aortic Valve Systems.
Authors: Choudhury T, Solomonica A, Bagur R Abstract INTRODUCTION: Transcatheter aortic valves have evolved over the last 15 years. Second- and third- generation devices have considerably improved, and a range of newer devices have also been introduced with the aim of decreasing the incidence of paravalvular leak, reducing the need for permanent pacemaker implantation and minimising procedure- and device-related complications. Areas covered: In this review, we highlight the special features of the latest generation of self-expanding Evolut PRO (Medtronic, Minneapolis, Minnesota) transcatheter aortic valve system. A...
Source: Expert Review of Medical Devices - December 7, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research