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Expert Review of Medical Devices

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https://www.readbyqxmd.com/read/30320521/the-mechanically-expandable-lotus-valve-and-lotus-edge-transcatheter-aortic-valve-systems
#1
Amir Solomonica, Tawfiq Choudhury, Rodrigo Bagur
The Lotus valve system (Boston Scientific, Marlborough, Massachusetts, USA) consists of a braided wire Nitinol™ frame with three bovine pericardial leaflets. The valve is deployed by controlled mechanical expansion which allows recapturing/repositioning and full retrievability. Areas covered:While this system offers a unique seal, which conforms to irregular surfaces, thereby minimizing paravalvular leak, its main downfall is a high rate of new pacemaker implantation. This had been partially addressed with the design of the Depth Guard™ mechanism to optimize deployment by early anchoring and limiting the depth of implant...
October 15, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30318937/principles-of-tavr-valve-design-modelling-and-testing
#2
Oren M Rotman, Matteo Bianchi, Ram P Ghosh, Brandon Kovarovic, Danny Bluestein
Transcatheter aortic valve replacement (TAVR) has emerged as an effective minimally-invasive alternative to surgical valve replacement in medium- to high-risk, elderly patients with calcific aortic valve disease and severe aortic stenosis. The rapid growth of the TAVR devices market has led to a high variety of designs, each aiming to address persistent complications associated with TAVR valves that may hamper the anticipated expansion of TAVR utility. Areas Covered: Here we outline the challenges and the technical demands that TAVR devices need to address for achieving the desired expansion, and review design aspects of selected, latest generation, TAVR valves of both clinically-used and investigational devices...
October 15, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30261148/mesh-implants-for-hernia-repair-an-update
#3
Uwe Klinge, Bernd Klosterhalfen
Today the use of textile meshes has become a standard for the treatment of abdominal wall hernias and for the reinforcement of any tissue repair as the strength of the implant decreases the recurrence rates. With increasing use, side effects of the textile implants became apparent, as well. Areas covered: Based on publications in Medline over the past decade, general and specific benefits, as well as risks, are discussed with the challenge to define individual risk-benefit ratios. For meshes, certain high-risk or low-risk conditions can be defined...
September 27, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30256687/the-acurate-neo-transcatheter-aortic-valve-system
#4
Tawfiq Choudhury, Amir Solomonica, Rodrigo Bagur
The field of transcatheter aortic valve implantation (TAVI) has seen an exponential expansion in available TAVI prostheses for the treatment of severe symptomatic aortic stenosis. Areas covered: The ACURATE neo (Boston Scientific, MA, USA) is a second-generation self-expanding transcatheter aortic valve system. The valve presents a supra-annular design, and comprises three stabilization arches for axial alignment, an upper-crown for capping the aortic annulus, and a lower-crown that is opened over the native aortic valve for full deployment...
September 26, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30247076/managing-large-lead-vegetations-in-transvenous-lead-extractions-using-a-percutaneous-aspiration-technique
#5
Christoph T Starck, Jürgen Eulert-Grehn, Marian Kukucka, Dirk Eggert-Doktor, Thomas Dreizler, Benjamin Haupt, Volkmar Falk
BACKGROUND: Treatment of patients with systemic infections of cardiac implantable electronic devices and large lead vegetations are a clinical challenge. In such situations patients potentially had to undergo open surgical extraction in the past. The objective of this study was to evaluate the results of a concomitant percutaneous, minimal-invasive aspiration procedure with the use of an extracorporeal circulation in transvenous lead extraction procedures in patients with large lead vegetations...
September 24, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30246569/interatrial-shunts-technical-approaches-to-percutaneous-closure
#6
Gianluca Rigatelli, Marco Zuin, Nguyen Tuong Nghia
Interatrial shunt closure is considered the first-line therapy for congenital simple communications such as patent forame ovale (PFO), atrial septal defect (ASD), and post surgical interatrial communications. Areas covered: Anatomical, functional, and technical details useful for planning a transcatheter-based closure procedure are discussed as well as the available equipments and their use and the procedural routes and the specific closure techniques. Expert commentary: Anatomical and functional details, appreciated at both pre-procedural and intraprocedural steps, are of paramount importance for planning interatrial shunts transcatheter - based closure procedures...
September 22, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30227754/mask-interface-for-continuous-positive-airway-pressure-therapy-selection-and-design-considerations
#7
Zhichao Ma, Michael Drinnan, Philip Hyde, Javier Munguia
Continuous positive airway pressure (CPAP) therapy is a clinical treatment for moderate or severe obstructive sleep apnea (OSA). Commercial CPAP mask designs normally come in standard sizes and the configuration is not commonly tailored to the patients' characteristics such as face topology, skin sensitivity, and severity of OSA syndrome; however, an optimal mask/interface selection is a key factor influencing the compliance and effectiveness of CPAP treatment. Areas covered: This review investigates the conventional CPAP mask design, its effect on OSA treatment, and the related risk factors that can lead to skin damage after long-term repeated use...
September 19, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30221561/total-artificial-heart-implantation-as-a-bridge-to-transplantation-a-viable-model-for-the-future
#8
Rachel A Beaupré, Oscar Howard Frazier, Jeffrey A Morgan
Since the first total artificial heart (TAH) surgery in a human patient performed in 1969, over 1300 devices have been implanted worldwide. Patients are benefiting from increased lengths of durable support and indications have expanded beyond biventricular failure including allograft failure, severe restrictive disease, and complex congenital anomalies. Areas covered: The role of the TAH in biventricular failure, rates of successful bridge-to-transplant (BTT), and survival compared with biventricular assist devices (BiVADs) are discussed and differences between TAH and LVAD patient populations are highlighted...
September 17, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30203999/total-knee-arthroplasty-in-the-face-of-a-previous-tuberculosis-infection-of-the-knee-what-do-we-know-in-2018
#9
Assem A Sultan, William A Cantrell, Emily Rose, Peter Surace, Linsen T Samuel, Morad Chughtai, Anton Khlopas, Jared M Newman, Joseph T Moskal, Michael A Mont
TB of the knee is often associated with marked morbidity because of its late and non-specific presentation. The use of TKA (total knee arthroplasty) in the face of a previous tuberculous knee infection has been criticized with multiple controversies. Therefore, the purpose of this review is to assess: (1) clinical outcomes, (2) radiographic outcomes, and (3) complications of TKA in the face of a previous healed TB infection. Our analysis has demonstrated that previous TB infection of the knee joint does not preclude TKA if indicated and suggests placing patients who have ESR or CRP results out of normal range on pre-operative anti-TB prophylactic antibiotic for a minimum of 2 weeks...
September 11, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30139282/tigr-matrix-for-implant-based-breast-reconstruction-a-long-term-resorbable-mesh
#10
Giulio Cuffolo, Nicholas C Holford, Kaiyumars Contractor, Alexandra Tenovici
The use of biological and synthetic meshes to aid implant coverage in implant-based breast reconstruction is well established. This technique allows single stage implant-based reconstruction compared to the traditional technique which required tissue expansion before permanent implant placement and therefore involved two operations for the patient. They can further be used for pre-pectoral implant reconstructions in a similar direct-to-implant strategy. This retrospective observational study by Pompei et al has evaluated the use of TIGR Matrix, a long-term resorbable mesh, in 49 patients with 60 operated breasts for both reconstructive and aesthetic cases...
September 10, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30134738/value-proposition-of-robotic-total-knee-arthroplasty-what-can-robotic-technology-deliver-in-2018-and-beyond
#11
Michael A Mont, Anton Khlopas, Morad Chughtai, Jared M Newman, Mathew Deren, Assem A Sultan
Robotic-assisted total knee arthroplasty (TKA) has undergone marked development and increasingly gained interest with multiple studies demonstrating excellent clinical and radiographic outcomes. However, a value assessment that encompasses other aspects related to the adoption of this technology is necessary to fully appreciate the cost/benefit ratio and potential present and future returns. Due to the relative paucity of evidence, this review was conducted to compare newer generation robotic TKA systems vs...
September 7, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30132713/histopathologic-and-physiologic-effect-of-overlapping-vs-single-coronary-stents-impact-of-stent-evolution
#12
Atsushi Sakamoto, Sho Torii, Hiroyuki Jinnouchi, Renu Virmani, Aloke V Finn
Bare metal stents (BMS) and drug eluting stents (DES) have been deployed in single and overlap configurations, the latter mostly to cover long-lesions. Both type of stents in overlap configuration increases the risk of adverse events. Areas covered: We present the rationale for either BMS or DES usage utilizing both preclinical and clinical studies for the use of single vs. overlapped stents. Further, employing experimental and pathological studies, we discuss the disadvantages of stent overlapping vs. single stenting and propose that vessel injury, local blood flow disturbance, higher drug/polymer dose are mechanisms leading to poor clinical outcomes including in-stent restenosis (ISR), delayed arterial healing, thrombosis, and hypersensitivity reactions...
September 7, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30179051/the-coronary-sinus-reducer-device-for-refractory-chronic-angina-rationale-clinical-evidence-and-future-perspectives
#13
Rocco A Montone, Michele Russo, Francesco Giannini, Giampaolo Niccoli
No abstract text is available yet for this article.
September 4, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30129382/going-beyond-the-high-risk-patient-the-new-boundaries-for-transcatheter-device-focused-therapy
#14
Damien P Kenny, Ziyad M Hijazi
Although congenital interventions continue to evolve to reach smaller and more complex patients, historically, adequate data collection and clinical trials have been lacking in comparison to adult coronary and structural interventions. This leads to difficulty in defining risk and providing meaningful data on risk-adjusted outcomes. Areas covered: Risk-adjusted models have been recently developed for congenital interventions, and pre-procedural risk calculators are reaching everyday practice, providing an estimate of procedural risk to gauge the validity of a particular approach...
August 30, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30099914/laryngoscopes-for-difficult-airway-scenarios-a-comparison-of-the-available-devices
#15
Lukasz Szarpak
According to the American Society of Anesthesiologists, the incidence of difficult intubation in the operating room is 1.2-3.8%; however, in emergency conditions, this rate is higher and reaches even 5.3%. Successful emergency airway management is an essential component of the modern practice of medicine. Areas covered: The aim of the study is to review the literature regarding different devices used to perform endotracheal intubation (Macintosh, Miller, and McCoy laryngoscopes; ETView, GlideScope, TruView, Airtraq, McGrath MAC, Pentax AWS, Trachlight, Shikani, and Bullard) and discuss their clinical and experimental role in difficult airway management...
August 30, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30132366/bicruciate-retaining-total-knee-arthroplasty-compared-to-cruciate-sacrificing-tka-what-are-the-advantages-and-disadvantages
#16
Florian Baumann
No abstract text is available yet for this article.
August 28, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30129782/catheter-based-closure-of-aortic-and-mitral-paravalvular-leaks-existing-techniques-and-new-frontiers
#17
Timothy A Joseph, Colleen E Lane, Erin A Fender, Chad J Zack, Charanjit S Rihal
Significant paravalvular leak (PVL) complicates between 6% and 15% of valve replacements and can result in heart failure and hemolysis. Paravalvular leak can be effectively treated with repeat surgery; however, these procedures are associated with significant operative morbidity. Percutaneous PVL closure is increasingly being utilized as the first line therapy for symptomatic patients, but efficacy may be limited by the lack of dedicated closure devices. Areas covered: This article will review the etiology and prevalence of PVL, discuss outcomes with surgical closure, describe the mounting data supporting percutaneous interventions, and highlight areas for future research emphasizing the need for new dedicated closure devices...
August 21, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30092660/shields-and-garb-for-decreasing-radiation-exposure-in-the-cath-lab
#18
Aris Karatasakis, Emmanouil S Brilakis
Decreasing radiation exposure of the cardiac catheterization laboratory staff is critical for minimizing radiation-related adverse outcomes and can be accomplished by decreasing patient dose and by shielding. Areas covered: protection from ionizing radiation can be achieved with architectural, equipment-mounted, and disposable shields, as well as with personal protective equipment. Expert commentary: Radiation protective aprons are the most commonly used personal protective equipment and provide robust radiation protection but can cause musculoskeletal strain...
August 20, 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30295541/an-overview-of-surgical-sealant-devices-current-approaches-and-future-trends
#19
Philipp Heher, James Ferguson, Heinz Redl, Paul Slezak
Wound leakage is a common complication after surgical incision or resection. In the past, a variety of clinically-approved surgical sealant devices have been used as an adjunct or alternative to conventional means of tissue sealing. However, there is still an unmet need for a sealant that can be universally applied over a wide range of clinical applications. This has further driven the emergence of both novel liquid surgical sealant devices and active hemostatic sealant patches to deal with the increasing complexity of surgical interventions in the field of hemorrhage control and wound leakage...
October 2018: Expert Review of Medical Devices
https://www.readbyqxmd.com/read/30095289/randomized-comparison-of-the-baska-fess-mask-and-the-lma-supreme-in-different-head-and-neck-positions
#20
Li Lian Foo, Ina Ismiarti Shariffuddin, Sook Hui Chaw, Pui Kuan Lee, Chong En Lee, Yi Shang Chen, Lucy Chan
BACKGROUND: The Baska functional endoscopic sinus surgery (FESS) mask is a new supraglottic airway designed for head and neck procedures. This prospective, randomized controlled trial compared the oropharyngeal leak pressure (OLP) of the Baska FESS mask with the laryngeal mask airway (LMA) Supreme in different head and neck positions. METHODS: One hundred patients undergoing elective surgery were recruited. OLP was compared in supine position, 45° lateral rotation, 45° neck extension, and 30° neck flexion...
August 2018: Expert Review of Medical Devices
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