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Medical Devices: Evidence and Research

Jeffrey D Coe, James F Zucherman, Donald W Kucharzyk, Kornelis A Poelstra, Larry E Miller, Sandeep Kunwar
The increasing adoption of minimally invasive techniques for spine surgery in recent years has led to significant advancements in instrumentation for lumbar interbody fusion. Percutaneous pedicle screw fixation is now a mature technology, but the role of expandable cages is still evolving. The capability to deliver a multiexpandable interbody cage with a large footprint through a narrow surgical cannula represents a significant advancement in spinal surgery technology. The purpose of this report is to describe a multiexpandable lumbar interbody fusion cage, including implant characteristics, intended use, surgical technique, preclinical testing, and early clinical experience...
2016: Medical Devices: Evidence and Research
Antoine Da Costa, Jean Baptiste Guichard, Cécile Roméyer-Bouchard, Antoine Gerbay, Karl Isaaz
Radiofrequency treatment represents the first choice of treatment for arrhythmias, in particular complex arrhythmias and especially atrial fibrillation, due to the greater benefit/risk ratio compared to antiarrhythmic drugs. However, complex arrhythmias such as atrial fibrillation require long procedures with additional risks such as X-ray exposure or serious complications such as tamponade. Given this context, the treatment of arrhythmias using robotic magnetic navigation entails a technique well suited to complex arrhythmias on account of its efficacy, reliability, significant reduction in X-ray exposure for both patient and operator, as well as a very low risk of perforation...
2016: Medical Devices: Evidence and Research
Paolo Bifulco, Gaetano Dario Gargiulo, Maria Romano, Mario Cesarelli
Reliable detection of pacemaker pulses is getting more and more important in electrocardiography (ECG) diagnosis. Many studies recommend ECG amplifiers with higher bandwidth to prevent errors. In the past, few pilot studies showed that analysis of pacemaker pulses waveform can enhance diagnosis (eg, lead failure and fractured wire), but they were carried out with inadequate instrumentations for clinical practice. Typically, pacemaker pulses last hundreds of microseconds, edges of pulses elapse in few microseconds, and amplitude may exhibit large variations from few millivolts to volts...
2016: Medical Devices: Evidence and Research
Dirk Schnabel, Carl-Joachim Partsch, Muriel Houang, Sarah Ehtisham, Helen Johnstone, Markus Zabransky, Wieland Kiess
BACKGROUND: A questionnaire-based survey was conducted to assess attitudes toward a reusable self-injection system (SurePal™) among pediatric patients with growth disturbances who were prescribed treatment with Omnitrope(®) within routine clinical practice. METHODS: This was a multicenter, observational study, incorporated into the noninterventional PAtients TReated with Omnitrope(®) (PATRO) Children study. Included subjects, or their caregivers, completed a questionnaire on the following five main areas: attractiveness of SurePal™, training received, using the device, the low drug wastage system, and experience versus other devices used previously (pretreated patients)...
2016: Medical Devices: Evidence and Research
Martin J Swaans, Lisette Is Wintgens, Arash Alipour, Benno Jwm Rensing, Lucas Va Boersma
Atrial fibrillation (AF) is the most common arrhythmia treated in the clinical practice. One of the major complications of AF is a thromboembolic cerebral ischemic event. Up to 20% of all strokes are caused by AF. Thromboembolic cerebral ischemic event in patients with AF occurs due to atrial thrombi, mainly from the left atrial appendage (LAA). Prevention of clot formation with antiplatelet agents and especially oral anticoagulants (vitamin K antagonists or newer oral anticoagulants) has been shown to be effective in reducing the stroke risk in patients with AF but has several drawbacks with (major) bleedings as the most important disadvantage...
2016: Medical Devices: Evidence and Research
Simin Asadian, Alireza Khatony, Gholamreza Moradi, Alireza Abdi, Mansour Rezaei
INTRODUCTION: An accurate determination of body temperature in critically ill patients is a fundamental requirement for initiating the proper process of diagnosis, and also therapeutic actions; therefore, the aim of the study was to assess the accuracy and precision of four noninvasive peripheral methods of temperature measurement compared to the central nasopharyngeal measurement. METHODS: In this observational prospective study, 237 patients were recruited from the intensive care unit of Imam Ali Hospital of Kermanshah...
2016: Medical Devices: Evidence and Research
Leonard I Voronov, Krzysztof B Siemionow, Robert M Havey, Gerard Carandang, Avinash G Patwardhan
INTRODUCTION: Lateral mass screw (LMS) fixation with plates or rods is the current standard procedure for posterior cervical fusion. Recently, implants placed between the facet joints have become available as an alternative to LMS or transfacet screws for patients with cervical spondylotic radiculopathy. The purpose of this study was to evaluate the biomechanical stability of the DTRAX(®) cervical cage for single- and two-level fusion and compare this to the stability achieved with LMS fixation with rods in a two-level construct...
2016: Medical Devices: Evidence and Research
Stephanie S Hwang, Mark C Takata, Ken Fujioka, William Fuller
There are many different methods of treating obesity, ranging from various medical options to several surgical therapies. This paper briefly summarizes current surgical options for weight loss with a focus on one of the newest US Food and Drug Administration-approved devices for surgical weight loss therapy, the Maestro Rechargeable System. Also known as the vagal blocking for obesity control implantable device, this tool blocks vagal nerve activity to induce weight loss.
2016: Medical Devices: Evidence and Research
David B Douglas, Emanuel F Petricoin, Lance Liotta, Eugene Wilson
PURPOSE: The purpose of this article is to present images from simulated breast microcalcifications and assess the pattern of the microcalcifications with a technical development called "depth 3-dimensional (D3D) augmented reality". MATERIALS AND METHODS: A computer, head display unit, joystick, D3D augmented reality software, and an in-house script of simulated data of breast microcalcifications in a ductal distribution were used. No patient data was used and no statistical analysis was performed...
2016: Medical Devices: Evidence and Research
Jason J Howard
Due to problems with wear particle generation and subsequent loosening using conventional metal-on-polyethylene total hip replacements, there has been a shift toward alternative bearing systems, including metal-on-metal (MoM), for younger, more active patients with degenerative joint disease. Based on positive results from early short-term clinical studies, MoM hip replacements were readily adopted by orthopedic surgeons with thousands being implanted worldwide over the past decade. Unacceptably high revision rates reported by two national joint registries called into question the rigorousness of the regulatory approval process for these implants, particularly with respect to premarket data requirements to prove safety, effectiveness, and the appropriateness of the regulatory pathway chosen...
2016: Medical Devices: Evidence and Research
Purushothaman Geethanjali
Myoelectric signals (MES) have been used in various applications, in particular, for identification of user intention to potentially control assistive devices for amputees, orthotic devices, and exoskeleton in order to augment capability of the user. MES are also used to estimate force and, hence, torque to actuate the assistive device. The application of MES is not limited to assistive devices, and they also find potential applications in teleoperation of robots, haptic devices, virtual reality, and so on...
2016: Medical Devices: Evidence and Research
Robert L Hill, John G Wilmot, Beth A Belluscio, Kevin Cleary, David Lindisch, Robin Tucker, Emmanuel Wilson, Rajesh B Shukla
Parenteral routes of drug administration are often selected to optimize actual dose of drug delivered, assure high bioavailability, bypass first-pass metabolism or harsh gastrointestinal environments, as well as maximize the speed of onset. Intramuscular (IM) delivery can be preferred to intravenous delivery when initiating intravenous access is difficult or impossible. Drugs can be injected intramuscularly using a syringe or an automated delivery device (autoinjector). Investigation into the IM delivery dynamics of these methods may guide further improvements in the performance of injection technologies...
2016: Medical Devices: Evidence and Research
Sean M Morell, Richard E McCarthy
Early-onset scoliosis is a complex condition with multiple facets. The goal of treating any spinal deformity is to improve the condition of the patient with the least intervention necessary. A system that allows for continuation of natural spinal growth while correcting the deformity should be the goal of treating this complex condition. The SHILLA growth guidance system allows for continued growth of the pediatric spine while correcting and guiding the apex and guiding the future growth of the curvature. The system involves selective fusion across the apex of the curvature, and minimally invasive instrumentation is then used above and below the apex to allow for continued growth of the spine...
2016: Medical Devices: Evidence and Research
Michael Friebe
There has been little technical innovation over the last few years for contrast media (CM) injectors that are used for diagnostic imaging (computed tomography [CT], magnetic resonance imaging [MRI], and hybrid imaging systems, such as positron emission tomography-CT or magnetic resonance-positron emission tomography) examinations. The medical need of CM for the enhancement of diagnostic images has been around for a long time, but the application of the CM into the blood stream comes with potential medical complications for the patient and requires a lot of operator experience and training...
2016: Medical Devices: Evidence and Research
Leonard I Voronov, Krzysztof B Siemionow, Robert M Havey, Gerard Carandang, Frank M Phillips, Avinash G Patwardhan
INTRODUCTION: Supplemental posterior instrumentation has been widely used to enhance stability and improve fusion rates in higher risk patients undergoing anterior cervical discectomy and fusion (ACDF). These typically involve posterior lateral mass or pedicle screw fixation with significant inherent risks and morbidities. More recently, cervical cages placed bilaterally between the facet joints (posterior cervical cages) have been used as a less disruptive alternative for posterior fixation...
2016: Medical Devices: Evidence and Research
Donald Sachs, Don Kovalsky, Andy Redmond, Robert Limoni, S Craig Meyer, Charles Harvey, Dimitriy Kondrashov
BACKGROUND: Sacroiliac joint (SIJ) fusion (SIJF), first performed 95 years ago, has become an increasingly accepted surgical option for chronic SIJ dysfunction. Few studies have reported intermediate- or long-term outcomes after SIJF. OBJECTIVE: The objective of this study is to determine patient-based outcomes after SIJF for chronic SIJ dysfunction due to degenerative sacroiliitis or SIJ disruption at ≥3 years of follow-up. METHODS: Consecutive patients who underwent SIJF prior to December 2012 were contacted over phone or through email...
2016: Medical Devices: Evidence and Research
Gheorghe Doros, Philip T Lavin, Michael Daley, Larry E Miller
Although the concept of equivalence for drugs (generics) and biologics (biosimilars) has been readily adopted, the concept of equivalence or indistinguishable characteristics for class III medical devices has yet to be specifically addressed regarding a defined regulatory approval process in the US. In September 2015, GenVisc 850® (sodium hyaluronate), a hyaluronic acid approved for the treatment of knee osteoarthritis, was approved by the US Food and Drug Administration (FDA) based upon indistinguishable characteristics in comparison to an approved branded hyaluronic acid (Supartz®/Supartz FX™)...
2016: Medical Devices: Evidence and Research
Melissa S Engel, Lazaros K Kochilas
Congenital heart disease (CHD) is one of the most common birth defects, with an incidence of nine out of every 1,000 live births. The mortality of infants with CHD has decreased over the past 3 decades, but significant morbidity and mortality continue to occur if not diagnosed shortly after birth. Pulse oximetry was recommended as a screening tool to detect critical CHD in 2011 by the American Academy of Pediatrics and the American Heart Association. Pulse oximetry is a tool to measure oxygen saturation, and based on the presence of hypoxemia, many cardiac lesions are detected...
2016: Medical Devices: Evidence and Research
Giuseppe Giacchi, Luis Ortega-Paz, Salvatore Brugaletta, Kohki Ishida, Manel Sabaté
Coronary bioresorbable vascular scaffolds are a new appealing therapeutic option in interventional cardiology. The most used and studied is currently the Absorb BVS™. Its backbone is made of poly-L-lactide and coated by a thin layer of poly-D,L-lactide, it releases everolimus and is fully degraded to H2O and CO2 in 2-3 years. Absorb BVS™ seems to offer several theoretical advantages over metallic stent, as it gives temporary mechanical support to vessel wall without permanently caging it. Therefore, long-term endothelial function and structure are not affected...
2016: Medical Devices: Evidence and Research
Billy H Cordon, Nirmish Singla, Ajay K Singla
The artificial urinary sphincter (AUS), which has evolved over many years, has become a safe and reliable treatment for stress urinary incontinence and is currently the gold standard. After 4 decades of existence, there is substantial experience with the AUS. Today AUS is most commonly placed for postprostatectomy stress urinary incontinence. Only a small proportion of urologists routinely place AUS. In a survey in 2005, only 4% of urologists were considered high-volume AUS implanters, performing >20 per year...
2016: Medical Devices: Evidence and Research
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