Expert review of medical devices
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Expert Rev Med Devices · Jul 2006
Review Comparative StudyArtificial lung: progress and prototypes.
Lung disease is the fourth leading cause of death (one in seven deaths) in the USA. Acute respiratory distress syndrome (ARDS) affects approximately 150,000 patients a year in the USA, and an estimated 16 million Americans are afflicted with chronic lung disease, accounting for 100,000 deaths per year. Medical management is the standard of care for initial therapy, but is limited by the progression of disease. ⋯ PAL prototypes tested on both normal sheep and the absolute lethal dose smoke/burn-induced ARDS sheep model have demonstrated initial success in achieving total gas exchange. Still, clinical trials cannot begin until bio- and hemodynamic compatibility challenges are reconciled. The PAL initial design goals are for a short-term (weeks) bridge to recovery or transplant, but eventually, for long-term support (months).
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Expert Rev Med Devices · May 2006
Amplatzer Duct Occluder device: a new technology for the closure of the moderate-to-large-sized patent ductus arteriosus.
The Amplatzer Duct Occluder is a novel device designed to allow for the transcatheter closure of virtually all sized patent ductus arteriosuses. Prior technologies have been cumbersome and challenging to deploy with somewhat less than ideal closure rates associated with their use. This article summarizes the present knowledge about the Amplatzer Duct Occluder device and its various indications. With the introduction of this device as well as the use of embolization coils, all but the neonatal patent ductus arteriosuses can now be safely, consistently and successfully closed in the cardiac catheterization laboratory.
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Expert Rev Med Devices · Mar 2006
ReviewCerebral oxygenation monitoring: near-infrared spectroscopy.
Neurological complications during critical illness remain a frequent cause of morbidity and mortality. To date, monitors of cerebral function including electroencephalography, jugular bulb mixed venous oxygen saturation and transcranial Doppler, either require an invasive procedure and/or are not sensitive enough to effectively identify patients at risk for cerebral hypoxia. Near-infrared spectroscopy is a noninvasive device that uses infrared light, a technique similar to pulse oximetry, to penetrate living tissue and estimate brain tissue oxygenation by measuring the absorption of infrared light by tissue chromophores. The following article reviews the latest technology available to monitor cerebral oxygenation, near-infrared spectroscopy, its advantages and disadvantages, the currently available evidence-based medicine that demonstrates that this technology can identify deficits in cerebral oxygenation, and that monitoring such deficits allows for therapy to reverse cerebral oxygenation issues and thereby prevent long-term neurological sequelae.
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Expert Rev Med Devices · Nov 2005
ReviewMedical devices for the diagnosis and treatment of obstructive sleep apnea.
Obstructive sleep apnea is increasingly being recognized as a serious public health problem, and is characterized by repetitive, complete or partial closure of the upper airway during sleep, resulting in sleep fragmentation and oxygen desaturation. The key symptoms of obstructive sleep apnea are snoring, witnessed apneas, excessive daytime sleepiness and deficits in neurocognitive function, adversely impacting on quality of life. The last 10 years have seen a steady increase in evidence linking obstructive sleep apnea to long-term cardiovascular morbidity, including hypertension, myocardial infarction and stroke, and an increased risk of motor vehicle accidents. ⋯ Similarly, on the therapeutic front, advances in continuous positive airway pressure technology have broadened the use of such treatment, although compliance remains an important impediment to widespread treatment of this common disorder. This has prompted a search for simpler treatment alternatives, ranging from surgical, medical and dental therapies, although none have matched the efficacy of continuous positive airway pressure. Advances in our understanding of the neurobiology of sleep and respiration herald the prospect of pharmacologic treatment in the longer term.
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Expert Rev Med Devices · Sep 2005
ReviewHeartMate II left ventricular assist device: a new device for advanced heart failure.
Since the initial use of artificial heart devices decades ago, advances in technology have yielded new artificial heart devices that can finally achieve the goal of providing life-saving treatment and good quality of life in terminally ill patients with heart failure. The HeartMate II left ventricular assist device is a new generation of device that is small, quiet and relatively easy to implant. A pilot study in the USA recently completed enrollment, and the pivotal trial is now underway to study this device in patients who are awaiting transplant and patients who are not candidates for transplant. To date, the results look promising that this device may be widely applicable to patients who have heart failure that do not respond to conventional treatments.