Expert review of medical devices
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Expert Rev Med Devices · Sep 2016
ReviewMobile health in cardiology: a review of currently available medical apps and equipment for remote monitoring.
Recent developments in implantable cardioverter-defibrillators (ICDs) and smartphone technology have increased the possibilities for remote monitoring. It is the purpose of this review to give an overview of these new possibilities. ⋯ Remote monitoring in ICD allows for early detection of lead fractures and remote follow-up of patients. Possible limitations are the lack of standardization and the possible unsafety of the data stored on the ICD. Secondly, remote monitoring of health parameters using smartphone compatible wearables and smartphone medical apps is addressed. Possible limitations include the fact that the majority of smartphone apps are unregulated by the regulatory authorities and privacy issues such as selling of app-generated data to third parties. Lastly, clinical studies with smartphone apps are discussed. Expert commentary: New technologies in ICDs and smartphones have the potential to be used for remote monitoring. However, unreliability of smartphone technology, inadequate legislation and lack of reimbursement impede implementation.
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Expert Rev Med Devices · Aug 2016
ReviewNovel cryoneurolysis device for the treatment of sensory and motor peripheral nerves.
Cryoneurolysis is the direct application of low temperatures to reversibly ablate peripheral nerves to provide pain relief. Recent development of a handheld cryoneurolysis device with small gauge probes and an integrated skin warmer broadens the clinical applications to include treatment of superficial nerves, further enabling treatments for pre-operative pain, post-surgical pain, chronic pain, and muscle movement disorders. ⋯ Cryoneurolysis is the direct application of cold temperatures to a peripheral nerve, resulting in reversible ablation due to Wallerian degeneration and nerve regeneration. Use over the last 50 years attests to a very low incidence of complications and adverse effects. Cryoprobes have traditionally been applied through a surgical incision; but, recent technical advances allow percutaneous administration. A new hand-held device is now approved for use within the United States. Cryoneurolysis has been used to treat postoperative and chronic pain states as well as spasticity. Expert commentary: Changes in the US healthcare system such as a push for the reduction of opioid use and the incorporation of Diagnostic Related Group codes, as well as recent technological advances including a handheld unit that allows for treatment of superficial nerves while protecting the skin from damage, may contribute to the resurgence of cryoneurolysis for the treatment of peripheral nerves.
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Expert Rev Med Devices · May 2016
Evaluation of advanced cooling therapy's esophageal cooling device for core temperature control.
Managing core temperature is critical to patient outcomes in a wide range of clinical scenarios. Previous devices designed to perform temperature management required a trade-off between invasiveness and temperature modulation efficiency. ⋯ Clinical data from cardiac arrest, fever, and critical burn patients indicate that the Esophageal Cooling Device performs very well both in terms of temperature modulation (cooling rates of approximately 1.3°C/hour, warming of up to 0.5°C/hour) and maintaining temperature stability (variation around goal temperature ± 0.3°C). Physicians have reported that device performance is comparable to the performance of intravascular temperature management techniques and superior to the performance of surface devices, while avoiding the downsides associated with both.
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Expert Rev Med Devices · Jan 2016
ReviewDevelopments in mechanical thrombectomy devices for the treatment of acute ischemic stroke.
Several recent prospective randomized controlled trials of endovascular stroke therapy using latest generation thrombectomy devices, so called stent-retrievers, have shown significantly improved clinical outcome compared to the standard treatment with intra-venous thrombolysis using r-tPA alone. Despite some differences in inclusion criteria between these studies, all required non-invasive vessel imaging to proof occlusion of a major brain supplying vessel. ⋯ Patients with small infarct volume, severe neurological deficits and in whom thrombectomy can be initiated within the first 6 hours after symptom onset seem to benefit the most. Therefore, mechanical thrombectomy using stent-retrievers in addition to intra-venous thrombolysis is recommended for the treatment of acute ischemic stroke with proven major vessel occlusion in the anterior circulation.
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Expert Rev Med Devices · Jan 2016
ReviewVisions on the future of medical devices in spinal cord stimulation: what medical device is needed?
Recently burst stimulation and 10 kHz stimulation have been developed as novel stimulation designs. Both appear to be superior to classical tonic stimulation in the amount of responders and the amount of pain suppression and have as an extra advantage that they are paresthesia-free. ⋯ This evolution mandates a new approach in the development of internal pulse generators, and the most obvious approach is to develop an upgradable stimulator, on which new stimulation designs can be downloaded, analogous to the apps people download on their smartphones. This will create a shift from hardware driven products to software driven stimulators.