Abstract:
INTRODUCTION:Transcatheter devices have contributed significantly to the advances achieved in treating many cardiovascular conditions over the last few decades. Sophisticated and detailed preclinical testing is not only a regulatory requirement to support an investigational device exemption (IDE) application, but more crucially its success and accuracy is needed to safeguard patients during the subsequent clinical testing stages. Areas covered: This article covers the regulatory background as well as specific considerations related to pre-clinical testing of transcatheter devices. Expert commentary: The lifecycle of a device is complex, but the period of commercialization may be short with little time for manufacturers to recuperate the costs associated with device development and (pre) clinical testing. Regulatory bodies such as the FDA require comprehensive data on pre-clinical testing prior to considering approval of an investigational device exemption to start trials in humans, which should include some data on safety and efficacy of a device. Preclinical testing needs to evaluate a variety of factors, such biocompatibility, material performance, durability, toxicology, particulation, protection against user error and device malfunction, potential hazards, and many more.
journal_name
Expert Rev Med Devicesjournal_title
Expert review of medical devicesauthors
Holzer R,Goble J,Hijazi Zdoi
10.1080/17434440.2017.1282313subject
Has Abstractpub_date
2017-02-01 00:00:00pages
87-92issue
2eissn
1743-4440issn
1745-2422journal_volume
14pub_type
杂志文章abstract::To obtain data for maternal stroke volume and cardiac output during pregnancy, it is preferable to use a non-invasive, accurate and reproducible method. In this aspect, impedance cardiography is an excellent technique which is also highly accessible and easy to perform. This paper is a comprehensive review on the publ...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2013.853466
更新日期:2013-11-01 00:00:00
abstract::Prosthetic heart valves are routinely used for replacing diseased natural heart valves. Even today, after five decades of prosthetic heart valve development, in the authors opinion the main problem associated with these valves is the risk of thromboembolic complications caused by unnatural hemodynamics. Further growin...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2.1.61
更新日期:2005-01-01 00:00:00
abstract::Background: Saline is not biocompatible with saphenous vein grafts and does not protect against ischemia reperfusion injury. We compared normal heparinized saline with DuraGraft, a new graft-storage solution, in in-vitro and ex-vivo assays to evaluate the effects on cells and vascular graft tissue.Methods: Human saphe...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2019.1682996
更新日期:2019-11-01 00:00:00
abstract::This article focuses on the surface engineering of ventricular assist devices (VADs) for the treatment of heart failure patients, which involves the modification of surfaces contacting blood in order to improve the blood compatibility (hemocompatibility) of the VADs. Following an introduction to the categorization and...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.6.1.51
更新日期:2009-01-01 00:00:00
abstract::Glaucoma is a leading cause of blindness worldwide. Currently, topical drops are the mainstay of treatment for patients who suffer from this chronic disease. Adherence to topical therapy is known to be affected by forgetfulness, frequent dosing requirements and physical limitations. Dosing and adherence aids are desig...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.4.2.261
更新日期:2007-03-01 00:00:00
abstract::Introduction: Theranostics is an emerging field in which diagnosis and specific targeted therapy are combined to achieve a personalized treatment approach to the patient. In nuclear medicine clinical practice, theranostics is often performed utilizing the same molecule labeled with two different radionuclides, one rad...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2020.1741348
更新日期:2020-04-01 00:00:00
abstract:INTRODUCTION:Improved survival following single ventricle palliation has led to a large population of patients with a univentricular circulation, many of whom develop heart failure. Increasing experience with ventricular assist devices (VAD) in children has paved the way for VAD support in those with failing univentric...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2017.1332523
更新日期:2017-06-01 00:00:00
abstract:INTRODUCTION:First-generation drug-eluting stents (DES) were developed and indeed proved their superiority compared to bare-metal stent in minimizing neo-intimal hyperplasia and in-stent restenosis (ISR), overall, reducing target vessel revascularization (TVR). Newer-generation DES are characterized by thinner struts, ...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1080/17434440.2018.1549986
更新日期:2019-01-01 00:00:00
abstract::There has been considerable development and implementation of new contraceptive methods over the last 15 years. However, sterilization has remained the most widely used method around the world. Ideally, the procedure should be safe, have a high efficacy, be readily accessible, and be personally and culturally acceptab...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.5.4.525
更新日期:2008-07-01 00:00:00
abstract:INTRODUCTION:Anastomotic leak (AL) after colorectal surgery is a devastating complication; decreased blood perfusion is an important risk factor. Surgeons rely on subjective measures to assess bowel perfusion. Fluorescence imaging (FI) with indocyanine green (ICG) provides a real-time objective assessment of intestinal...
journal_title:Expert review of medical devices
pub_type: 杂志文章,meta分析,评审
doi:10.1080/17434440.2017.1265444
更新日期:2017-01-01 00:00:00
abstract:INTRODUCTION:Spinal cord stimulation has emerged as a state-of-the-art evidence-based treatment for chronic neuropathic pain and mixed nociceptive-neuropathic pain. In recent years, several newer devices and treatment algorithms have provided unique and effective ways of treating chronic pain by spinal cord stimulation...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2019.1567325
更新日期:2019-02-01 00:00:00
abstract:INTRODUCTION:Recurrent unexplained syncope is a well-established indication for an insertable cardiac monitor (ICM). Recently, the indications for an ICM have been expanded. AREAS COVERED:This review article discusses the current indications for ICMs and gives an overview of the latest generation of commercially avail...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2018.1557046
更新日期:2019-01-01 00:00:00
abstract::Conventional hemostatic technologies utilized in thyroid surgery include clamp-and-tie, clips and monopolar and bipolar diathermy. Over the last decade, there has been a major shift towards utilizing newer hemostatic technologies, most notably the electrothermal bipolar vessel sealing systems (EBVS) and the Harmonic S...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.13.6
更新日期:2013-05-01 00:00:00
abstract::The subthalamic nucleus (STN) is the primary target for the chronic deep brain stimulation treatment of Parkinson's disease. STN neurons exhibit a variety of characteristic properties that may play a key role in the overall population response to deep brain stimulation. Neuroinformatics techniques, in particular compu...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.4.5.663
更新日期:2007-09-01 00:00:00
abstract:INTRODUCTION:Monitoring a patient's vital signs forms a basic component of care, enabling the identification of deteriorating patients and increasing the likelihood of improving patient outcomes. Several paper-based track and trigger warning scores have been developed to allow clinical evaluation of a patient and guida...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2019.1563480
更新日期:2019-02-01 00:00:00
abstract::Over the last decade, the use of electrosurgical devices has become commonplace across all surgical specialities. The current market is large enough to warrant a comparative review of each device. This has even more impetus given the budgetary constraints of NHS organisations. This review aims to compare the benefits ...
journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1586/17434440.2016.1134312
更新日期:2016-01-01 00:00:00
abstract::The evidence on digital breast tomosynthesis (DBT), or quasi-3D-mammography, for population breast screening has emerged rapidly: two prospective and several retrospective studies provide convincing evidence that mammography with DBT improves screening detection measures compared with standard mammography. Based on po...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2015.1028362
更新日期:2015-07-01 00:00:00
abstract::Consumer sleep tracking devices such as fitness trackers and smartphone apps have become increasingly popular. These devices claim to measure the sleep duration of their users and in some cases purport to measure sleep quality and awaken users from light sleep, potentially improving overall sleep. Most of these device...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2016.1171708
更新日期:2016-05-01 00:00:00
abstract::Precise and accurate biomechanical reconstruction during total hip arthroplasty (THA) is essential for durable long-term survivorship. Accurate fit of cementless hip implants is also crucial to reduce micromotion between the bone-implant interfaces to allow for stable osseointegration. Robotic technology aims to minim...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2016.1124018
更新日期:2016-01-01 00:00:00
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journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2.4.409
更新日期:2005-07-01 00:00:00
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journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.882226
更新日期:2014-03-01 00:00:00
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journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.882767
更新日期:2014-03-01 00:00:00
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journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.907741
更新日期:2014-05-01 00:00:00
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journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.929492
更新日期:2014-09-01 00:00:00
abstract::The rescue of autogenous angioaccess for hemodialysis can be performed surgically or radiologically. For the latter, there is current debate as to whether a mechanical hydrodynamic device confers a clinical advantage over a rotational thrombectomy. The evaluated article describes a single center retrospective cohort s...
journal_title:Expert review of medical devices
pub_type: 评论,杂志文章
doi:10.1586/erd.12.75
更新日期:2013-01-01 00:00:00
abstract::For decades, electroactive polymers received relatively little attention due to their limited actuation capability. However, in the last 15 years, a series of electroactive polymer materials have emerged that produce a significant shape or size change in response to electrical stimulation. These materials have the clo...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2.6.731
更新日期:2005-11-01 00:00:00
abstract::MRI is the gold standard diagnostic tool for soft tissue imaging for many specialties. An impressive body of research has proven the effectiveness of cardiac rhythm management devices (CRMDs) objectively, in terms of parameters that include patient's quality of life, morbidity, and mortality. However, interaction betw...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/17434440.2014.882228
更新日期:2014-03-01 00:00:00
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journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1080/17434440.2017.1389636
更新日期:2017-11-01 00:00:00
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journal_title:Expert review of medical devices
pub_type: 杂志文章
doi:10.1586/17434440.4.4.447
更新日期:2007-07-01 00:00:00
abstract::Transforaminal percutaneous endoscopic lumbar discectomy is regarded as an effective alternative to open discectomy. Remarkable technical evolution now enables selective endoscopic removal of an epidurally extruded disc fragment. As a result, the surgical indications for this technique are becoming broader. However, a...
journal_title:Expert review of medical devices
pub_type: 杂志文章,评审
doi:10.1586/erd.12.23
更新日期:2012-07-01 00:00:00