Expert review of medical devices
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Expert Rev Med Devices · Jan 2015
Evaluation of Zoll Medical's ResQCPR System for cardiopulmonary resuscitation.
Cardiac arrest remains a leading cause of death, currently affecting more than 250,000 Americans annually. As recommended by the American Heart Association, the current standard of care for patients with an out-of-hospital cardiac arrest (OHCA) includes manual cardiopulmonary resuscitation (S-CPR). ⋯ A recent Phase III, multicenter randomized study demonstrated a 50% increase in survival to hospital discharge with favorable neurologic function in subjects with an OHCA of presumed cardiac etiology treated with the ResQCPR System compared with conventional CPR. The ResQCPR System has been recently approved by the FDA as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest.
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Expert Rev Med Devices · Nov 2014
ReviewPercutaneous endoscopic decompression for lumbar spinal stenosis.
Percutaneous endoscopic lumbar discectomy has become a representative minimally invasive spine surgery for lumbar disc herniation. Due to the remarkable evolution in the techniques available, the paradigm of spinal endoscopy is shifting from treatments of soft disc herniation to those of lumbar spinal stenosis. ⋯ However, these techniques are continuously evolving. In the near future, PED for lumbar stenosis may be an efficient alternative to conventional open lumbar decompression surgery.
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Expert Rev Med Devices · Nov 2014
ReviewThe RNS System: responsive cortical stimulation for the treatment of refractory partial epilepsy.
The RNS(®) System is the first commercially available device to provide closed-loop responsive brain stimulation. The system includes a cranially implanted neurostimulator that continually monitors the electrocorticogram through one or two depth and/or subdural cortical strip leads that are placed at the seizure focus. ⋯ Safety and effectiveness of the RNS System for the indicated patient population was demonstrated in a multicenter, randomized, sham-stimulation controlled 2-year pivotal study. An ongoing, prospective, long-term treatment study is currently gathering an additional 7 years of prospective safety and effectiveness data of the RNS System.
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Expert Rev Med Devices · Nov 2014
EditorialBCI-FES: could a new rehabilitation device hold fresh promise for stroke patients?
It has been known that stroke constitutes a major source of acquired disability, with nearly 800,000 new strokes each year in the USA alone. While advances in public and preventative health have helped reduce stroke incidence in high-income countries in recent decades, growth of the aging population, increasing stroke rates in low- to middle-income countries and medical advances that have reduced stroke mortality are all contributing to an increase in stroke survivors worldwide. Large numbers of stroke survivors have residual motor deficits. This editorial will provide an introduction to a class of new therapies being investigated with the aim of improving motor outcomes in stroke patients that uses what is known as brain-computer interface technology.
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Expert Rev Med Devices · Sep 2014
ReviewThe lung volume reduction coil for the treatment of emphysema: a new therapy in development.
Lung volume reduction (LVR) coil treatment is a novel therapy for patients with severe emphysema. In this bilateral bronchoscopic treatment, approximately 10 LVR coils per lobe are delivered under fluoroscopic guidance in two sequential procedures. The LVR coil reduces lung volume by compressing the most destructed areas of the lung parenchyma and restores the lung elastic recoil. ⋯ The LVR-coil treatment has been evaluated in several European clinical trials since 2008 and received CE mark approval in 2010. Currently, two large multicenter randomized controlled trials are underway in Europe and North America to assess the efficacy and safety of the LVR-coil treatment at 12 months compared with usual care. In this review, we share our experience with the LVR-coil treatment.