Effect of energy-based devices on post-operative parathyroid function and blood calcium levels after total thyroidectomy
Expert Rev Med Devices. 2021 Mar 5. doi: 10.1080/17434440.2021.1899805. Online ahead of print.ABSTRACTINTRODUCTION: Energy-based devices are widely used in thyroid surgery in order to achieve optimal hemostasis, while their role in the incidence of hypocalcemia and hypoparathyroidism comprises a topic evaluated in numerous studies.AREAS COVERED: The aim of this systematic review is to investigate the potential benefit of Ultrasonic Shears and Electrothermal Bipolar (Radiofrequency) System in thyroid surgery regarding the incidence of post-operative hypocalcemia and hypoparathyroidism. A systematic review of the literature ...
Source: Expert Review of Medical Devices - March 5, 2021 Category: Medical Devices Authors: Eleftherios Spartalis Alexios Giannakodimos Afroditi Ziogou Ilias Giannakodimos Stavroula A Paschou Michael Spartalis Dimitrios Schizas Theodore Troupis Source Type: research

A Novel Fast-Acting Sub-Perception Spinal Cord Stimulation Therapy Enables Rapid Onset of Analgesia in Patients with Chronic Pain
We describe attainment of clinically meaningful and rapid-onset analgesic outcomes using a novel sub-perception SCS approach.Methods: This observational case-series evaluated patients implanted with an SCS device for chronic pain, who underwent re-programming utilizing a new methodology in which paresthesia was used to guide sub-perception stimulation field targeting at specific parameters including charge-balanced symmetrical pulses at 90Hz (termed Fast-Acting Sub-Perception Therapy, FAST). Pain scores (NRS) were collected as reported per standard-of-care from patient charts. Energy usage was quantified as charge delivere...
Source: Expert Review of Medical Devices - March 3, 2021 Category: Medical Devices Authors: Clark S Metzger Blake Hammond M Jose F Paz-Solis William J Newton Simon J Thomson Yu Pei Roshini Jain Michael Moffitt Luca Annecchino Que Doan Source Type: research

Intraoperative OCT microscopy in 3D
Expert Rev Med Devices. 2021 Mar 2. doi: 10.1080/17434440.2021.1898374. Online ahead of print.NO ABSTRACTPMID:33651642 | DOI:10.1080/17434440.2021.1898374 (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - March 2, 2021 Category: Medical Devices Authors: Adam Wyl ęgała Adam Sendecki Edward Wyl ęgała Source Type: research

The FlowOx device for the treatment of peripheral artery disease: current status and future prospects
Expert Rev Med Devices. 2021 Feb 25. doi: 10.1080/17434440.2021.1895750. Online ahead of print.NO ABSTRACTPMID:33632040 | DOI:10.1080/17434440.2021.1895750 (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - February 26, 2021 Category: Medical Devices Authors: Henrik Hoel Jonny Hisdal Source Type: research

Use of XyCAM RI for Noninvasive Visualization and Analysis of Retinal Blood Flow Dynamics During Clinical Investigations
Expert Rev Med Devices. 2021 Feb 26. doi: 10.1080/17434440.2021.1892486. Online ahead of print.ABSTRACTINTRODUCTION: Ocular blood flow plays a critical role in eye health by nourishing the retinal and ocular tissues with oxygen and nutrients and removal of ocular metabolic waste. Imaging of retinal and optic blood flow may provide insights for early and more specific diagnoses of ocular vascular disorder and facilitate eye-based biomarkers applicable to neurological health assessment and research.AREAS COVERED: The ability of the XyCAM RI (Vasoptic Medical Inc., MD, USA) to visualize and to analyze ocular blood flow dynami...
Source: Expert Review of Medical Devices - February 26, 2021 Category: Medical Devices Authors: Delia Cabrera DeBuc Abhishek Rege William E Smiddy Source Type: research

The FlowOx device for the treatment of peripheral artery disease: current status and future prospects
Expert Rev Med Devices. 2021 Feb 25. doi: 10.1080/17434440.2021.1895750. Online ahead of print.NO ABSTRACTPMID:33632040 | DOI:10.1080/17434440.2021.1895750 (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - February 26, 2021 Category: Medical Devices Authors: Henrik Hoel Jonny Hisdal Source Type: research

Use of XyCAM RI for Noninvasive Visualization and Analysis of Retinal Blood Flow Dynamics During Clinical Investigations
Expert Rev Med Devices. 2021 Feb 26. doi: 10.1080/17434440.2021.1892486. Online ahead of print.ABSTRACTINTRODUCTION: Ocular blood flow plays a critical role in eye health by nourishing the retinal and ocular tissues with oxygen and nutrients and removal of ocular metabolic waste. Imaging of retinal and optic blood flow may provide insights for early and more specific diagnoses of ocular vascular disorder and facilitate eye-based biomarkers applicable to neurological health assessment and research.AREAS COVERED: The ability of the XyCAM RI (Vasoptic Medical Inc., MD, USA) to visualize and to analyze ocular blood flow dynami...
Source: Expert Review of Medical Devices - February 26, 2021 Category: Medical Devices Authors: Delia Cabrera DeBuc Abhishek Rege William E Smiddy Source Type: research

The FlowOx device for the treatment of peripheral artery disease: current status and future prospects
Expert Rev Med Devices. 2021 Feb 25. doi: 10.1080/17434440.2021.1895750. Online ahead of print.NO ABSTRACTPMID:33632040 | DOI:10.1080/17434440.2021.1895750 (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - February 26, 2021 Category: Medical Devices Authors: Henrik Hoel Jonny Hisdal Source Type: research

Use of XyCAM RI for Noninvasive Visualization and Analysis of Retinal Blood Flow Dynamics During Clinical Investigations
Expert Rev Med Devices. 2021 Feb 26. doi: 10.1080/17434440.2021.1892486. Online ahead of print.ABSTRACTINTRODUCTION: Ocular blood flow plays a critical role in eye health by nourishing the retinal and ocular tissues with oxygen and nutrients and removal of ocular metabolic waste. Imaging of retinal and optic blood flow may provide insights for early and more specific diagnoses of ocular vascular disorder and facilitate eye-based biomarkers applicable to neurological health assessment and research.AREAS COVERED: The ability of the XyCAM RI (Vasoptic Medical Inc., MD, USA) to visualize and to analyze ocular blood flow dynami...
Source: Expert Review of Medical Devices - February 26, 2021 Category: Medical Devices Authors: Delia Cabrera DeBuc Abhishek Rege William E Smiddy Source Type: research

The FlowOx device for the treatment of peripheral artery disease: current status and future prospects
Expert Rev Med Devices. 2021 Feb 25. doi: 10.1080/17434440.2021.1895750. Online ahead of print.NO ABSTRACTPMID:33632040 | DOI:10.1080/17434440.2021.1895750 (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - February 26, 2021 Category: Medical Devices Authors: Henrik Hoel Jonny Hisdal Source Type: research

Use of XyCAM RI for Noninvasive Visualization and Analysis of Retinal Blood Flow Dynamics During Clinical Investigations
Expert Rev Med Devices. 2021 Feb 26. doi: 10.1080/17434440.2021.1892486. Online ahead of print.ABSTRACTINTRODUCTION: Ocular blood flow plays a critical role in eye health by nourishing the retinal and ocular tissues with oxygen and nutrients and removal of ocular metabolic waste. Imaging of retinal and optic blood flow may provide insights for early and more specific diagnoses of ocular vascular disorder and facilitate eye-based biomarkers applicable to neurological health assessment and research.AREAS COVERED: The ability of the XyCAM RI (Vasoptic Medical Inc., MD, USA) to visualize and to analyze ocular blood flow dynami...
Source: Expert Review of Medical Devices - February 26, 2021 Category: Medical Devices Authors: Delia Cabrera DeBuc Abhishek Rege William E Smiddy Source Type: research

Mitral valve surgery: current status and future prospects of the minimally invasive approach
Expert Rev Med Devices. 2021 Feb 24. doi: 10.1080/17434440.2021.1894925. Online ahead of print.ABSTRACTIntroduction. During the past five years the approach to procedural planning, operative techniques and perfusion strategies for minimally invasive mitral valve surgery (MIMVS) has evolved. With the goal to provide a maximum of patient safety the procedure has been modified according to individual patient characteristics and is largely based on preoperative imaging.Areas covered. In this review article we describe the important factors in image based therapy planning and simulation, different access strategies, the operati...
Source: Expert Review of Medical Devices - February 24, 2021 Category: Medical Devices Authors: Karel M Van Praet J örg Kempfert Stephan Jacobs Christof Stamm Serdar Akansel Markus Kofler Simon H S ündermann Timo Z Nazari Shafti Katharina Jakobs Stefan Holzendorf Axel Unbehaun Volkmar Falk Source Type: research

Toward improving functional recovery in Spinal Cord Injury using Robotics: a Pilot Study focusing on ankle rehabilitation.
Authors: Calabrò RS, Billeri L, Ciappina F, Balletta T, Porcari B, Cannavò A, Pignolo L, Manuli A, Naro A Abstract BACKGROUND: Conventional physical therapy interventions are strongly recommended to improve ambulation potential and upright mobility in persons with incomplete spinal cord injury (iSCI). Ankle rehabilitation plays a significant role, as it aims to stem drop foot consequences. RESEARCH QUESTION: This pilot study aimed to assess the neurophysiological underpinnings of robot-aided ankle rehabilitation (using a platform-robot) compared to conventional physiotherapy and its efficacy in im...
Source: Expert Review of Medical Devices - February 23, 2021 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Device profile of the Inspiris Resilia Valve for aortic valve replacement: overview of its safety and efficacy.
Authors: Tamagnini G, Bourguignon T, Rega F, Verbrugghe P, Lamberigts M, Langenaeken T, Meuris B Abstract INTRODUCTION: The Inspiris Resilia tissue valve was recently introduced into clinical practice, envisioning use as a tissue valve in younger patients. This review summarizes the pre-clinical and clinical studies leading to this new bioprosthesis. AREAS COVERED: The novel Resilia tissue was tested extensively in a large animal model. The clinical use of the tissue started in 2011 with the European Feasibility study, followed by a North-American multi-center study. Since 2017, the Inspiris Resilia valve has b...
Source: Expert Review of Medical Devices - February 17, 2021 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Management of out-of hospital cardiac arrest patients with extracorporeal cardiopulmonary resuscitation in 2021.
Authors: Gaisendrees C, Vollmer M, Walter SG, Djordjevic I, Eghbalzadeh K, Kaya S, Elderia A, Ivanov B, Gerfer S, Kuhn E, Sabashnikov A, Kahlert HA, Deppe AC, Kröner A, Mader N, Wahlers T Abstract INTRODUCTION: Over the last decade, eCPR programs have become more and more popular, at least amongst high-volume centers. Despite its rise in popularity and promising outcome, strategies concerning pre- and post-implantation of VA-ECMO remain at least debatable. Besides, integrating the appropriate set-up, managing anticoagulation, implementing LV-venting, and predicting neurological outcome play important roles in ...
Source: Expert Review of Medical Devices - February 6, 2021 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Computer-Assisted Surgery in Medical and Dental Applications.
Authors: Chen YW, Hanak BW, Yang TC, Wilson TA, Hsia JM, Walsh HE, Shih HC, Nagatomo KJ Abstract INTRODUCTION: Computer-assisted surgery (CAS) is a broad surgical methodology that utilizes computer technology to both plan and execute surgical intervention. CAS is widespread in both medicine and dentistry as it allows for minimally invasive and precise surgical procedures. Key innovations in volumetric imaging, virtual surgical planning software, instrument tracking and robotics have all assisted in facilitating the transfer of surgical plans to precise execution of surgical procedures. CAS has long been used in cer...
Source: Expert Review of Medical Devices - February 6, 2021 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Negative pressure wound therapy: device design, indications, and the evidence supporting its use.
This article reviews the history, background, and physiology underlying NPWT, as well as the most commonly used devices. In addition, an evidence-based discussion of the current clinical applications of NPWT is presented, with a focus on those with high levels of evidence. EXPERT OPINION: Future directions for device development include modifications to increase ease of use by patients and to allow its use in a broader array of anatomic areas. Lastly, more research with high levels of evidence is needed to better define the outcomes associated with NPWT, including in relation to specific clinical applications and cost....
Source: Expert Review of Medical Devices - January 28, 2021 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Thyroid Cancer Diagnosis with Transdermal Probe 22G U/S versus EBUS-Convex Probe TBNA-B 22G and 19G: Pros and Cons.
CONCLUSION: The method of biopsy should be made based on the size and accessibility of the lesion. PMID: 33482695 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - January 24, 2021 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The new generation double layered Flow Diverters for endovascular treatment of intracranial aneurysms: Current status of ongoing clinical uses.
Authors: Pavlov O, Shrivastava A, Moscote-Salazar LR, Mishra R, Gupta A, Agrawal A Abstract INTRODUCTION: The treatment of intracranial aneurysms has significantly evolved over the last decade with the advancement in endovascular techniques and devices. Flow diverters are the latest in the armamentarium for vascular reconstruction, aneurysm exclusion and preservation of branch vesses. The possibility of treating various types of intracranial aneurysms, including those previously considered untreatable, has represented a new paradigm in the neurovascular era. AREAS COVERED: This paper describes in detail the cur...
Source: Expert Review of Medical Devices - January 23, 2021 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Acute Postoperative Pain Management with Percutaneous Peripheral Nerve Stimulation: The SPRINT Neuromodulation System.
Authors: Gabriel RA, Ilfeld BM Abstract INTRODUCTION: Ultrasound-guided percutaneous peripheral nerve stimulation (PNS) may be used to treat acute postoperative pain for various types of surgeries. This modality avoids several limitations of traditional local anesthetic based peripheral nerve blocks including avoidance of motor blockade and sensory deficits. AREAS COVERED: In this review, we discuss the use of SPRINT (SPR Therapeutics, Cleveland, OH) neuromodulation system in the setting of acute postoperative pain management. EXPERT OPINION: PNS is a novel modality in regional anesthesia that has much prom...
Source: Expert Review of Medical Devices - January 17, 2021 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Diagnostic yield and safety of the ProCore versus the standard EBUS-TBNA needle in subjects with suspected sarcoidosis.
CONCLUSIONS: : We found no statistical difference in the sensitivity, specimen adequacy, or safety of EBUS-TBNA when performed with the ProCore or the Olympus needle in subjects with sarcoidosis. Larger studies are required to confirm our findings.[clinicaltrials.gov: NCT03656003]. PMID: 33435733 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - January 14, 2021 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Pacing devices to treat bradycardia: current status and future perspectives.
Authors: Biffi M, Capobianco C, Spadotto A, Bartoli L, Sorrentino S, Minguzzi A, Piemontese GP, Angeletti A, Toniolo S, Statuto G Abstract INTRODUCTION: Cardiac simulation evolved from life-saving devices to prevent asystole to the treatment of heart rhythm disorders and heart failure, capable of remote patient and disease-progression monitoring. Cardiac stimulation nowadays aims to correct the electrophysiologic roots of mechanical inefficiency in different structural heart diseases. AREAS COVERED: Clinical experience, as per available literature, has led to awareness of the concealed risks of customary cardia...
Source: Expert Review of Medical Devices - December 19, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Device profile of the XVision-spine (XVS) augmented-reality surgical navigation system: overview of its safety and efficacy.
Authors: Dibble CF, Molina CA Abstract INTRODUCTION: The field of augmented reality mediated spine surgery is growing rapidly and holds great promise for improving surgical capabilities and patient outcomes. Augmented reality can assist with complex or atypical cases involving challenging anatomy. As neuronavigation evolves, fundamental technical limitations remain in line-of-sight interruption and operator attention shift, which this novel augmented reality technology helps to address. AREAS COVERED: XVision is a recently FDA-approved head mounted display for intraoperative neuronavigation, compatible with all...
Source: Expert Review of Medical Devices - December 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Baska Mask versus Endotracheal tube in Laparoscopic Cholecystectomy Surgery: A Prospective Randomized Trial.
This study compared the efficacy and safety of the Baska Mask with endotracheal tube (ETT) in patients undergoing elective laparoscopic cholecystectomy. RESEARCH DESIGN AND METHODS: This single-center, prospective, randomized controlled trial recruited 60 patients aged 18-75 years with American Society of Anesthesiologists' classifications I to III. The time taken to achieve effective airway, number of attempts, ease of insertion, ventilation parameters, hemodynamics data, and pharyngolaryngeal complications were recorded. RESULTS: The time taken to achieve effective airway was shorter for the Baska group (26.6&plu...
Source: Expert Review of Medical Devices - December 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Reflection efficiencies of AnaConDa-S and AnaConDa-100 for isoflurane under dry laboratory and simulated clinical conditions: a bench study using a test lung.
CONCLUSION: Under DRY and concentrations
Source: Expert Review of Medical Devices - December 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Correction.
Authors: PMID: 33317344 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 17, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Device profile of the LithoVue single-use digital flexible ureteroscope in the removal of kidney stones: overview of safety and efficacy.
Authors: Forbes CM, Lundeen C, Beebe S, Moore JP, Knudsen BE, Humphreys MR, Chew B Abstract Introduction: Flexible ureteroscopy is a commonly performed urologic procedure for visualization and treatment of the upper urinary tracts. Traditionally, ureteroscopy has been performed with reusable scopes, which have large initial purchasing costs. LithoVue was the first widely adopted single-use flexible ureteroscope clinically available in 2016 and has caused reevaluation of this paradigm. Areas covered: This review is an objective assessment of the LithoVue single-use ureteroscope based on available studies at the time...
Source: Expert Review of Medical Devices - December 15, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Percutaneous Laser Ablation of Cervical Metastatic Lymph Nodes in Papillary Thyroid Carcinoma: Clinical Efficacy and Anatomical Considerations.
CONCLUSIONS: : LAT is relatively safe and effective for the treatment of cervical metastatic lymph nodes in patients with papillary thyroid carcinoma. PMID: 33307870 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 15, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The role of growth hormone device optimization in patient-reported outcomes: real-world evidence from South Korea.
Authors: Lee JE, Lee KH, Park MJ, Yang S, Kim EY, Rhie YJ, Jung MH, Yang A, Kim SH, Chung LY, Ko SY, Lee YJ, Nedjatian N, Chung WY Abstract BACKGROUND: : Growth hormone (GH) treatment preference and adherence are affected by delivery device convenience, injection-site pain, confidence in correct dose administration, and satisfaction with the device. This survey investigated if switching device to NordiFlex® improved treatment experience in pediatric patients in South Korea. DESIGN AND METHODS: : Patients aged 4-≤18 years were surveyed. Participants were NordiFlex® users who previously used NordiLet&r...
Source: Expert Review of Medical Devices - December 15, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

EEG modulation by different transcranial direct current stimulation (tDCS) montages: a randomized double-blind sham-control mechanistic pilot trial in healthy participants.
Conclusion: This pilot study despite having low statistical power given its small sample size shows that active left DLPFC tDCS modulates EEG frontocentrally and suggests that electrode shapes/reference locations affect its neurophysiological effects, such as increased low alpha power at AF3 using circular vs. rectangular electrodes. Further research with more participants is warranted. PMID: 33305643 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 12, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Review of safety reports of cardiac MR-Imaging in patients with recently implanted coronary artery stents at various field strengths.
Conclusion: Independent of MRI field strength (1.5 Tesla or 3.0 Tesla) or used stent type (BMS or DES), there was no increased rate for cardiac events in patients, who underwent MRI
Source: Expert Review of Medical Devices - December 11, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

A Review on the Applications of Virtual Reality, Augmented Reality and Mixed Reality in Surgical Simulation: An Extension to Different Kinds of Surgery.
The objective of this review is to provide a comprehensive overview of the application of VR, AR and MR for distinct surgical disciplines, including maxillofacial surgery and neurosurgery. The current developments in these areas, as well as potential future directions, are discussed. EXPERT OPINION: The key components for incorporating VR into surgical simulators are visual and haptic rendering. These components ensure that the user is completely immersed in the virtual environment and can interact in the same way as in the physical world. The key components for the application of AR and MR into surgical simulators inc...
Source: Expert Review of Medical Devices - December 9, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Cardiac contractility modulation for the treatment of moderate to severe HF.
This article will discuss the science behind CCM therapy, the presumed mechanisms of action, the pre-clinical studies that shaped subsequent endeavors, and the clinical trials that support its use. Expert opinion: The introduction of CCM therapy bridges a therapeutic gap for patients with few or no other therapeutic options for NYHA III heart failure. PMID: 33287592 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - December 9, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Trends and Technologies in Rehabilitation of Foot Drop: A Systematic Review.
Authors: Alnajjar F, Khalid S, Zaier R, Gochoo M Abstract INTRODUCTION: Foot Drop (FD) is a condition, which is very commonly found in post-stoke patients, however it can also be seen in patients with multiple sclerosis, and cerebral palsy. It is a sign of neuromuscular damage caused by the weakness of the muscles. There are various approaches of FD's rehabilitation, such as physiotherapy, surgery, and the use of technological devices. Recently, researchers have worked on developing various technologies to enhance assisting and rehabilitation of FD. AREAS COVERED: This review analyzes different types of technol...
Source: Expert Review of Medical Devices - December 2, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The realization of robotic neurorehabilitation in clinical: use of computational intelligence and future prospects analysis.
This article reviews the state of the art and advances of robotic neurorehabilitation with computational intelligence. We classified advances into two categories: mechanical structures and control methods. Prospective outlooks of rehabilitation robots also have been discussed. Expert opinion: The aggravation of global aging has promoted the application of robotic technology in neurorehabilitation. However, this approach is not mature enough to guarantee the safety of patients. Our critical review summarizes multiple computation algorithms which have been proved to be valuable for better robotic use in clinical settings and...
Source: Expert Review of Medical Devices - December 2, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Prevention and management of endocarditis in transcatheter pulmonary valve replacement: current status and future prospects.
Authors: McElhinney DB Abstract Introduction: Transcatheter pulmonary valve replacement (TPVR) has become a important tool in the management of congenital heart disease with abnormalities of the right ventricular outflow tract. Endocarditis is one of the most serious adverse long-term outcomes and among the leading causes of death in patients with congenital heart disease and after (TPVR). Areas Covered: This review discusses the current state knowledge about the risk factors for and outcomes of endocarditis after transcatheter pulmonary valve replacement in patients with congenital and acquired heart disease. It a...
Source: Expert Review of Medical Devices - November 29, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Long term safety and efficacy of breast biopsy markers in clinical practice.
CONCLUSION: : Placement of breast biopsy markers is safe with minimal associated risks. Issues related to device malfunction, durability, reliability, safety, or performance were not reported. PMID: 33233969 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - November 27, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Profile of Somryst Prescription Digital Therapeutic for Chronic Insomnia: Overview of Safety and Efficacy.
Authors: Morin CM Abstract Introduction: Prescription digital therapeutics (PDTs) represent a new class of software-based medical devices authorized by the Food and Drug Administration (FDA) to treat disease. Somryst™, the first PDT authorized by FDA for treating chronic insomnia, delivers cognitive behavioral therapy for insomnia (CBT-I) via a mobile application. CBT-I is the guideline-recommended, first-line treatment for chronic insomnia, but availability of CBT-I therapists is limited. Somryst addresses this need by providing asynchronous access to CBT-I treatment. As a contactless therapeutic medium, Som...
Source: Expert Review of Medical Devices - November 25, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

The current state of cervical endoscopic spine surgery: An updated literature review and technical considerations.
Authors: Ahn Y Abstract INTRODUCTION: Endoscopic spine surgery has become one of the representative minimally invasive spine surgeries (MISS), especially in the lumbar spine. Full-endoscopic procedures using a working channel endoscope for cervical degenerative spine disease have been reported as practical and feasible. This review aimed to summarize the updated techniques of and studies about cervical endoscopic surgery. Areas covered: An extensive search of PubMed was performed for randomized controlled trials (RCTs) or comparative cohort studies on the full-endoscopic cervical procedure. All the 236 articles fou...
Source: Expert Review of Medical Devices - November 21, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Agreement between anterior segment parameters obtained by a new ultrasound biomicroscopy and a swept-source fourier-domain anterior segment optical coherence tomography.
CONCLUSION: The values of CCT, LDiaangle and Rf obtained via 2 instruments were not clinically interchangeable and the AQD, ATA, LT and Rb have poor agreement affected by accommodation. We can estimate the real lens diameter by subtracting 0.61 ± 0.43mm when the lens diameter can only be simulated with SS-OCT. PMID: 33196325 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - November 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Safety and efficacy of repeat transcatheter aortic valve replacement for the treatment of transcatheter prosthesis dysfunction.
Authors: Faroux L, Alperi A, Muntané-Carol G, Rodes-Cabau J Abstract INTRODUCTION: Transcatheter aortic valve replacement (TAVR) has recently expanded toward the treatment of younger patients with lower surgical risk and longer life expectancy. Thus, transcatheter heart valve (THV) durability has become a central issue, and an important increase in the number of TAVR-in-TAVR is expected in the coming years. AREAS COVERED: Overview of the current status of TAVR-in-TAVR for the treatment of THV dysfunction, focusing on safety and efficacy of repeat TAVR procedures. EXPERT OPINION: An accurate analysis ...
Source: Expert Review of Medical Devices - November 18, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Clinical role of fluorescence imaging in colorectal surgery - an updated review.
This article will review the common and novel uses for fluorophores in colorectal surgery, including tissue perfusion for anastomotic creation, ureter identification, lymphatic mapping, and tumor localization. Expert opinion: The versatility of this technology permeates through many aspects of colorectal procedures. The white light spectrum has historically been the only available modality to visualize tissue perfusion, tumor implants, and structures including the ureters and lymph nodes. The ability of the near-infrared spectrum to penetrate biologic tissues allows the identification of these structures with injection of ...
Source: Expert Review of Medical Devices - November 17, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Gravitational shunt valves in hydrocephalus to challenge the sequelae of over-drainage.
Authors: Gutowski P, Gölz L, Rot S, Lemcke J, Thomale UW Abstract INTRODUCTION: In hydrocephalus treatment, ventriculo-peritoneal shunts (VPS) have become the most relevant therapy for seven decades among other treatment options. Due to the hydrostatic pressure in vertical position, CSF diversion is somehow non-physiological. The integration of gravitational valves in VPS was established to counteract the hydrostatic draining force and to approach a physiological condition of the cerebrospinal diverting system. Numerous clinical studies have shown that gravitational valves are able to reduce secondary complica...
Source: Expert Review of Medical Devices - November 14, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

An update on the ovation abdominal stent graft for the treatment of abdominal aortic aneurysms: current evidence and future perspectives.
Authors: Georgakarakos E, Papatheodorou N, Argyriou C, Tasopoulou KM, Doukas D, Georgiadis GS Abstract INTRODUCTION: : The Ovation stent-graft has presented satisfactory mid-term results in the management of abdominal aortic aneurysms (AAA). Its unique design with uncoupling of fixation and sealing and the lowest profile in the market has expanded the treatment in AAA with challenging neck anatomies and, especially, in the females presenting mostly with narrow iliac access vessels. Morever, a new design modification, the Ovation Alto was recently introduced in the Market, while certain off-label uses of the Ovation...
Source: Expert Review of Medical Devices - November 12, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Repeatability and agreement of corneal thickness measurements by three methods of pachymetry in small incision lenticule extraction eyes.
Authors: Hu L, Hu Z, Savini G, Yu J, Zhou H, Chen S, Ning R, Jin Y, Huang J Abstract Background: The accurate evaluation of corneal thickness (CT) post small incision lenticule extraction (SMILE) is clinically relevant to reduce the risk of complications. We aimed to analyze repeatability and agreement of central corneal thickness (CCT), thinnest corneal thickness (TCT) and mid-peripheral corneal thickness (MPCT) measurements using Scheimpflug imaging, anterior segment swept-source optical coherence tomography (AS-SS-OCT, CASIA 1000, Tomey) and ultrasound pachymetry (USP, SP-3000, Tomey) in eyes with previous SMILE...
Source: Expert Review of Medical Devices - November 4, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research

Preclinical validation of occupational and environmental safety of an isolation system for non-invasive ventilation in COVID-19 and other aerosol-transmitted infections.
CONCLUSION: Aerosolized markers were successfully contained within ISATI in all experimental simulations, offering occupational and environmental protection against the dissemination of aerosolized microparticles under CPAP or HFNO therapy conditions, which are indicated for patients with acute respiratory infections. PMID: 33103939 [PubMed - as supplied by publisher] (Source: Expert Review of Medical Devices)
Source: Expert Review of Medical Devices - October 28, 2020 Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research