Latest STEMI Treatment: A Focus on Current and Upcoming Devices.
Authors: Moscarella E, Brugaletta S, Sabaté M Abstract INTRODUCTION: Ischemic heart disease is the most common cause of mortality worldwide. In ST elevation myocardial infarction (STEMI) patients, optimization of primary percutaneous coronary intervention (pPCI) is crucial to improve myocardial savage and prevent reperfusion injury. In STEMI patients complicated with cardiogenic shock (CS), percutaneous mechanical circulatory support devices (MCS) have emerged as a therapeutic option in the management of this challenging condition and their use is rapidly increasing. Areas covered: In this review we discuss ...
Source: Expert Review of Medical Devices - October 24, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Reducing FDA Regulations for Medical Devices: Cutting Red Tape or Putting Patients' Lives at Risk?
Authors: Janetos TM, Xu RS, Walter JR, Xu S PMID: 30345824 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - October 24, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Dual mobility acetabular cups for total hip arthroplasty: advantages and drawbacks.
The objective of this review is to discuss the advantages and disadvantages of this implant based on its 40-year history and also to propose a range of indications based on published results. This will provide surgeons with a complete overview of DMC. Expert Commentary: Published studies on DMC confirm the low dislocation rate. Improvements made to DMC over time have greatly reduced the complications related to wear, such as aseptic loosening and intraprosthetic dislocation. According to the literature, the indications have expanded and are no longer limited to revision surgery only. Long-term studies are needed before we ...
Source: Expert Review of Medical Devices - October 24, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Lung volume reduction with endobronchial valves in patients with emphysema.
Authors: van der Molen MC, Klooster K, Hartman JE, Slebos DJ Abstract INTRODUCTION: Bronchoscopic lung volume reduction with endobronchial valves is a recently acknowledged treatment option in patients with severe emphysema and absence of interlobar collateral ventilation. In endobronchial valve treatment, implantation of one-way valves leads to deflation of a hyperinflated lung lobe. Multiple studies showed significant improvements in lung function, exercise capacity, and quality of life in this patient subgroup which often did not have any remaining treatment options. Areas covered: In this review, efficacy outco...
Source: Expert Review of Medical Devices - October 24, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Production of acoustic radiation force using ultrasound: methods and applications.
Authors: Urban MW Abstract INTRODUCTION: Acoustic radiation force (ARF) is used in many biomedical applications. The transfer of momentum in acoustic waves can be used in a multitude of ways to perturb tissue and manipulate cells. Areas Covered: This review will briefly cover the acoustic theory related to ARF, particularly that related to application in tissues. The use of ARF in measurement of mechanical properties will be treated in detail with emphasis on the spatial and temporal modulation of the ARF. Additional topics covered will be the manipulation of particles with ARF, correction of phase aberration with ...
Source: Expert Review of Medical Devices - October 24, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Principles of TAVR Valve Design, Modelling, and Testing.
Authors: Rotman OM, Bianchi M, Ghosh RP, Kovarovic B, Bluestein D Abstract INTRODUCTION: 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...
Source: Expert Review of Medical Devices - October 17, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The mechanically expandable LOTUS valve and LOTUS edge transcatheter aortic valve systems.
Authors: Solomonica A, Choudhury T, Bagur R Abstract INTRODUCTION: 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™ ...
Source: Expert Review of Medical Devices - October 17, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

An overview of surgical sealant devices: current approaches and future trends.
Authors: Heher P, Ferguson J, Redl H, Slezak P Abstract INTRODUCTION: 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 t...
Source: Expert Review of Medical Devices - October 10, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Mesh implants for hernia repair: an update.
Authors: Klinge U, Klosterhalfen B Abstract INTRODUCTION: 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. In an atte...
Source: Expert Review of Medical Devices - September 29, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The ACURATE neo transcatheter aortic valve system.
Authors: Choudhury T, Solomonica A, Bagur R Abstract INTRODUCTION: 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. This de...
Source: Expert Review of Medical Devices - September 27, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Interatrial shunts: technical approaches to percutaneous closure.
Authors: Rigatelli G, Zuin M, Nghia NT Abstract INTRODUCTION: 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 intraproced...
Source: Expert Review of Medical Devices - September 26, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Managing large lead vegetations in transvenous lead extractions using a percutaneous aspiration technique.
CONCLUSION: The presented data show that the aspiration procedure is safe and efficient as an adjunct in transvenous lead extraction procedures avoiding the need for open surgical extraction in such cases. PMID: 30247076 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - September 26, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Mask-interface for Continuous Positive Airway Pressure therapy: Selection and design considerations.
Authors: Ma Z, Drinnan M, Hyde P, Munguia J Abstract INTRODUCTION: 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 OS...
Source: Expert Review of Medical Devices - September 20, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Total artificial heart implantation as a bridge to transplantation: a viable model for the future?
Authors: Beaupré RA, Frazier OH, Morgan JA Abstract INTRODUCTION: Since the first total artificial heart (TAH) implant in a human patient in 1969, over 1300 devices have been implanted worldwide. Greater numbers of patients are receiving TAHs with an increased length of durable support and for indications beyond biventricular failure including allograft failure, severe restrictive or infiltrative disease, and complex congenital anomalies. Areas Covered: The role of the TAH in biventricular failure and its favorable rates of successful bridge-to-transplant (BTT) and survival compared to the biventricular assi...
Source: Expert Review of Medical Devices - September 19, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Total knee arthroplasty in the face of a previous tuberculosis infection of the knee: what do we know in 2018?
We examined reported outcomes of performing TKA in patients with previous TB infection of the knee. Different strategies recommended by different authors to maximize the success of TKA in this situation are also discussed. Expert commentary: TKA has been proven to be effective in patients who are status post tuberculous arthritis when thoughtful patient selection and peri-operative planning is conducted. Tuberculosis continues to have a rising incidence and increasing spread of multi-drug resistant strains. The number of patients with sequelae of knee tuberculous arthritis are expected to grow and better understanding of h...
Source: Expert Review of Medical Devices - September 13, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The coronary sinus Reducer device for refractory chronic angina: rationale, clinical evidence and future perspectives.
Authors: Montone RA, Russo M, Giannini F, Niccoli G PMID: 30179051 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - September 6, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Value proposition of robotic total knee arthroplasty: what can robotic technology deliver in 2018 and beyond?
Authors: Mont MA, Khlopas A, Chughtai M, Newman JM, Deren M, Sultan AA Abstract INTRODUCTION: 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. historic ones ...
Source: Expert Review of Medical Devices - August 25, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

TIGR Matrix for implant-based breast reconstruction - a long-term resorbable mesh.
This study is significant as there remains little data regarding the long term outcomes of resorbable synthetic mesh for breast reconstruction. Their reported complication rates are consistent with those in other studies for synthetic meshes. As synthetic meshes can be significantly cheaper than their biological counterparts, this work could promote more widespread use. PMID: 30139282 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - August 25, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Bicruciate-retaining total knee arthroplasty compared to cruciate-sacrificing TKA: what are the advantages and disadvantages?
Authors: Baumann F PMID: 30132366 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - August 24, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Histopathologic and physiologic effect of overlapping vs single coronary stents: impact of stent evolution.
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. We also explore whether newer generation (2nd generation) DES with reduced strut thickness, optimized drug releas...
Source: Expert Review of Medical Devices - August 24, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Going beyond the high-risk patient: the new boundaries for transcatheter device focused therapy.
Authors: Kenny DP, Hijazi ZM Abstract INTRODUCTION: 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 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 particula...
Source: Expert Review of Medical Devices - August 22, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Catheter-based closure of aortic and mitral paravalvular leaks: existing techniques and new frontiers.
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. Expert commentary: Percutaneous PVL closure can be safely accomplished in the majority of patients with PVL thereby avoiding the risks associated with repeat surgical intervention. However, percutaneous interventions are associated with higher rates of persistent leakage in part due to off-label use of devices intended for other applications. Efforts to develop dev...
Source: Expert Review of Medical Devices - August 22, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Laryngoscopes for difficult airway scenarios: a comparison of the available devices.
Authors: Szarpak L Abstract INTRODUCTION: 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)...
Source: Expert Review of Medical Devices - August 15, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Shields and garb for decreasing radiation exposure in the cath lab.
Authors: Karatasakis A, Brilakis ES Abstract INTRODUCTION: 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: shielding 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 strai...
Source: Expert Review of Medical Devices - August 11, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Randomised comparison of the Baska FESS mask and the LMA Supreme in different head and neck positions.
Authors: Foo LL, Shariffuddin II, Chaw SH, Lee PK, Lee CE, Chen YS, Chan L Abstract BACKGROUND: The Baska 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 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. Glottic view, insertion time, ease of insertion, number of attempts, ease...
Source: Expert Review of Medical Devices - August 11, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Current devices used for the monitoring of injection pressure during peripheral nerve blocks.
Authors: Gadsden J Abstract INTRODUCTION: Peripheral nerve blocks are generally safe. However, there is a small but real associated risk of needle-related complications such as nerve injury. Nerve injury has been associated with high pressure injections in animals, and some data supports the use of monitors to limit injection pressure during these procedures. Areas covered: A literature search for articles with keywords 'injection,' 'pressure,' and 'nerve' was conducted. All currently available devices designed to monitor injection pressure and/or prevent high pressure injections were reviewed. There are three clas...
Source: Expert Review of Medical Devices - August 8, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Recent advances in devices for vagus nerve stimulation.
Authors: Mertens A, Raedt R, Gadeyne S, Carrette E, Boon P, Vonck K Abstract INTRODUCTION: Vagus nerve stimulation (VNS) has become a valuable treatment option for refractory epilepsy and depression. To improve clinical efficacy and minimize side effects, novel device technology for vagus nerve stimulation is under development and investigation. Areas covered: For epilepsy, the AspireSR® and SenTiva™ VNS therapy systems are the 2 most recently developed VNS devices. These novel devices have implemented a closed-loop approach and contain a cardiac based seizure detection algorithm. The mechanism of action ...
Source: Expert Review of Medical Devices - August 4, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Identifying and addressing the limitations of EVAR technology.
Authors: Belvroy VM, Houben IB, Trimarchi S, Patel HJ, Moll FL, van Herwaarden JA Abstract INTRODUCTION: Endovascular aortic repair (EVAR) has improved over the last two decades. Approximately 80% of the patients presenting with an abdominal aortic aneurysm (AAA) is nowadays primarily treated with EVAR. Areas covered: In this review the differences between endovascular and open repair, the clinical characteristics needed for EVAR, the role of clinical imaging and the developments in EVAR technology will be discussed. Early mortality is lower in EVAR as compared to open repair, whereas this benefit is lost after thr...
Source: Expert Review of Medical Devices - August 2, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Removal and insertion of central venous catheters in cancer patients is associated with high symptom burden.
CONCLUSIONS: CVCs are essential for the management of cancer patients. However, they can become infected and may need to be removed. Catheter removal and insertion produced moderate to severe symptom burden in cancer patients. Safe interventions that would salvage the vascular access without worsening the infectious outcome should be explored to alleviate morbidity associated with the symptom burden of removal and re-insertion. PMID: 30067125 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - August 2, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Closed loop insulin delivery: current status of diabetes technologies and future prospects.
Authors: Majeed W, Thabit H Abstract INTRODUCTION: Type 1 diabetes is characterised by destruction of pancreatic beta cells, leading to insulin deficiency and hyperglycaemia. The mainstay of treatment remains lifelong insulin therapy as a sustainable cure has as yet proven elusive. The burden of daily management of type 1 diabetes has contributed to suboptimal outcomes for people living with the condition. Innovative technological approaches have been shown to improve glycaemic and patient-related outcomes. Areas covered: We discuss recent advances in diabetes technologies in type 1 diabetes and the 'artificial pan...
Source: Expert Review of Medical Devices - July 22, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Devices for penile traction: the long and winding road to treating Peyronie's disease.
Authors: Setia SA, Levine LA Abstract INTRODUCTION: Penile Traction Therapy (PTT) is increasingly being recognized as a viable non-surgical approach to Peyronie's Disease (PD). The goal of this article is to review the current literature on PTT with attention to traction protocols, devices, and outcomes. Areas Covered: Literature on the pathophysiology of PD, PTT as primary and adjunctive treatment for PD, perioperative use of PTT, and Vacuum Erection Devices are all reviewed. Pertinent literature was obtained from the PubMed database. The key words: "penile traction," "mechanotransduction," and...
Source: Expert Review of Medical Devices - July 19, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Optimal site selection & image fusion guidance technology to facilitate cardiac resynchronisation therapy.
Optimal site selection & image fusion guidance technology to facilitate cardiac resynchronisation therapy. Expert Rev Med Devices. 2018 Jul 18;: Authors: Sieniewicz BJ, Gould J, Porter B, Sidhu BS, Behar JM, Claridge S, Niederer S, Rinaldi CA Abstract INTRODUCTION: Cardiac resynchronisation therapy (CRT) has emerged as one of the few effective treatments for heart failure. However, up to 50% of patients derive no benefit. Suboptimal LV lead position is a potential cause of poor outcomes whilst targeted lead deployment has been associated with enhanced response rates. Image-fusion guidance systems r...
Source: Expert Review of Medical Devices - July 19, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The Visible Heart ® project and methodologies: novel use for studying cardiac monophasic action potentials and evaluating their underlying mechanisms.
We describe the historically proposed mechanisms behind which electrode is responsible for the MAP recording, new catheters for recording these signals, and how Visible Heart methodologies can be utilized to develop and test new technologies for electrophysiologic investigations. Expert Opinion: When compared to traditional electrogram recordings, MAP waveforms provide clinical information vital to the understanding, diagnosis, and treatment of cardiac arrhythmias. New catheters and ablation technologies are routinely being assessed on reanimated large mammalian hearts (swine and human) in our laboratory. These abilities, ...
Source: Expert Review of Medical Devices - July 12, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Artificial intelligence: a new clinical support tool for stress echocardiography.
Authors: Alsharqi M, Upton R, Mumith A, Leeson P PMID: 29992841 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - July 12, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Intra-observer and Inter-observer Reliability of Visible Light Spectroscopy During Upper Gastrointestinal Endoscopy.
CONCLUSIONS: The observer reliability of VLS is fair to good with intra-observer reliability being better than inter-observer reliability. This supports the use of VLS for detection of gastrointestinal ischemia. PMID: 29973094 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - July 6, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

3D printed upper limb prosthetics.
Authors: Vujaklija I, Farina D Abstract INTRODUCTION: In the last fifteen years, the market for prosthetic arms and hands has shifted towards systems with greater degrees of actuation. There has also been a progressive use of emerging technologies to overcome hardware design challenges. Moreover, the proliferation of rapid prototyping has resulted in applications in the prosthetic market. Even though there are concerns on robustness and wide-user acceptance, the affordable and customizable solution offered by rapid prototyping, combined with the possibility for easy maintenance and repair, is very attractive for pr...
Source: Expert Review of Medical Devices - June 29, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Regulatory convergence of medical devices: a case study using ISO and IEC standards.
Authors: Imagawa K, Mizukami Y, Miyazaki S Abstract INTRODUCTION: Achieving regulatory convergence is important in providing safe and effective medical devices to patients in a timely manner. The use of standards set by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), may be an important tool for regulatory convergence. The International Medical Device Regulators Forum (IMDRF) published a survey and statements regarding the use of these standards in each IMDRF jurisdiction, which showed that each jurisdiction proactively uses these standards in its re...
Source: Expert Review of Medical Devices - June 26, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Systematic review of agreement between tomosynthesis and pathologic tumor size for newly-diagnosed breast cancer and comparison with other imaging tests.
Authors: Marinovich ML, Macaskill P, Bernardi D, Houssami N Abstract Introduction Tomosynthesis is proposed to improve breast cancer assessment and staging as a complementary role to its detection capability. We examine the accuracy of tomosynthesis in measuring tumor size relative to pathology and compared with other tests. Areas covered A systematic literature search identified studies of tomosynthesis in estimating the size of newly-diagnosed breast cancers. Descriptive analyses were performed due to heterogeneity in patients, technology and methods between studies. Eight studies were eligible (678 patients). Me...
Source: Expert Review of Medical Devices - June 24, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The STENTYS self-apposing stent technology in coronary artery disease: literature review and future directions.
Authors: Lu H, de Winter RJ, Koch KT Abstract INTRODUCTION: Coronary stent designs have been through extensive developments in the past few decades. Since the first introduction of the self-apposing STENTYS stent, several theoretical advantages of its nitinol platform have been clinically evaluated. This paper reviews the current status, ongoing work and future directions of this device. Areas covered: The OPEN (STENTYS Coronary Bifurcation Stent System fOr the PErcutaNeous treatment of de novo lesions in native bifurcated coronary arteries) trials revealed high technical success rates of the STENTYS performance in...
Source: Expert Review of Medical Devices - June 24, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

International experience with minocycline, EDTA and ethanol lock for salvaging of central line associated bloodstream infections.
CONCLUSION: Our study suggests that M-EDTA-EtOH lock therapy may be an effective intervention to salvage long-term CVCs in the setting of CLABSI/CRBSI and hemodialysis cancer patients with limited vascular access. PMID: 29927699 [PubMed - in process] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - June 24, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Cardioband system as a treatment for functional mitral regurgitation.
Authors: Ferrero Guadagnoli A, De Carlo C, Maisano F, Ho E, Saccocci M, Cuevas O, Luciani M, Kuwata S, Nietlispach F, Taramasso M Abstract INTRODUCTION: Are the current data on the Cardioband in the clinical area enough to consider it a tool for mitral regurgitation treatment? Severe secondary mitral valve insufficiency frequently affects high-risk surgical patients. The Cardioband system is a novel percutaneous surgical-like device for direct annuloplasty. It is implanted into the beating heart by transvenous femoral access, with minimal impact on hemodynamic and cardiac function during implantation. So far, it ha...
Source: Expert Review of Medical Devices - June 9, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

A Review of Haptic Simulator for Oral and Maxillofacial Surgery Based on Virtual Reality.
Authors: Chen X, Hu J Abstract INTRODUCTION: Traditional medical training in oral and maxillofacial surgery may be limited by its low efficiency and high price due to the shortage of cadaver resources. With the combination of visual rendering and feedback force, surgery simulators become increasingly popular in hospitals and medical schools as an alternative to the traditional training. Areas covered: The major goal of this review is to provide a comprehensive reference source of current and future developments of haptic oral and maxillofacial surgery simulators based on virtual reality for relevant researchers. Ex...
Source: Expert Review of Medical Devices - June 6, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Security of implantable medical devices with wireless connections: the dangers of cyber-attacks.
Authors: Pycroft L, Aziz TZ PMID: 29860880 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - June 5, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

3D printing techniques in spine surgery: the future prospects and current challenges.
Authors: Wu AM, Lin JL, Kwan KYH, Wang XY, Zhao J PMID: 29848086 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - June 2, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Use of lasers in minimally invasive spine surgery.
The objective of this review is to describe the surgical applications of laser technology in MISS and to discuss the pros and cons of laser spine surgery. Areas covered: We reviewed the medical literature to identify how lasers are being used in the current MISS techniques. We also described a variety of laser spine surgery according to the laser employed and surgical approach. There are three categories of laser surgery in MISS: (1) open microscopic laser surgery; (2) percutaneous endoscopic laser surgery; and (3) laser tissue modulation for spinal pain. Even though numerous laser procedures and related case series have d...
Source: Expert Review of Medical Devices - June 2, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Evaluation of the Macy Catheter ®: A rectal catheter for rapid medication and fluid administration.
Evaluation of the Macy Catheter®: A rectal catheter for rapid medication and fluid administration. Expert Rev Med Devices. 2018 May 30;: Authors: Macygin KMC, Kulstad E, Mokszycki RK, Goldsmith M Abstract INTRODUCTION: Health care providers are increasingly challenged to balance cost considerations for devices, drugs, and staffing all while continuing to provide excellent care. Patients in both the post-acute and acute care settings often require fluid and/or medication when their oral route is compromised and vascular access may not be warranted or immediately accessible. The rectum is an underuti...
Source: Expert Review of Medical Devices - June 1, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Agreement of white-to-white measurements with the IOLMaster 700, Atlas 9000 and Sirius systems.
CONCLUSIONS: According to our results, these three devices should not be used interchangeably for WTW diameter measurements during the clinical practice. PMID: 29806949 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - May 30, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The Real World of blood glucose Point-of-Care Testing (POCT) System Running in China Teaching Hospital.
CONCLUSIONS: Our data indicates that the real world use of the POCT system in hospital settings in China needs more closer adherence to a quality management framework. PMID: 29737214 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - May 9, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Therapeutic options for functional mitral regurgitation in chronic heart failure.
Authors: Lowry JE, Fichtlscherer S, Witte KK Abstract INTRODUCTION: Mitral regurgitation is a common finding in patients with chronic heart failure and is associated with a progressive worsening of symptoms, reduced survival and increased cost of care. However, the use of mitral valve surgery for these patients remains controversial and has not been shown to improve survival. Consequently, research has been increasingly directed towards the nonsurgical management of this important co-morbidity of heart failure. Areas covered: The present review will describe the relevance of mitral regurgitation in people with chro...
Source: Expert Review of Medical Devices - May 7, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The potential for machine learning algorithms to improve and reduce the cost of 3-dimensional printing for surgical planning.
Authors: Huff TJ, Ludwig PE, Zuniga JM Abstract INTRODUCTION: 3D-printed anatomical models play an important role in medical and research settings. The recent successes of 3D anatomical models in healthcare have led many institutions to adopt the technology. However, there remain several issues that must be addressed before it can become more wide-spread. Of importance are the problems of cost and time of manufacturing. Machine learning (ML) could be utilized to solve these issues by streamlining the 3D modeling process through rapid medical image segmentation and improved patient selection and image acquisition. T...
Source: Expert Review of Medical Devices - May 5, 2018 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research