Expert review of medical devices最新文献_第7页

Review of mechanisms of expandable spine surgery devices. 回顾可扩张脊柱手术装置的机制。

Expert review of medical devices Pub Date : 2024-05-01 Epub Date: 2024-04-01 DOI: 10.1080/17434440.2024.2337295

Yuncong Mao, Arpan A Patel, Seth Meade, Edward Benzel, Michael P Steinmetz, Thomas Mroz, Ghaith Habboub

{"title":"Review of mechanisms of expandable spine surgery devices.","authors":"Yuncong Mao, Arpan A Patel, Seth Meade, Edward Benzel, Michael P Steinmetz, Thomas Mroz, Ghaith Habboub","doi":"10.1080/17434440.2024.2337295","DOIUrl":"10.1080/17434440.2024.2337295","url":null,"abstract":"Introduction: Expandable devices such as interbody cages, vertebral body reconstruction cages, and intravertebral body expansion devices are frequently utilized in spine surgery. Since the introduction of expandable implants in the early 2000s, the variety of mechanisms that drive expansion and implant materials have steadily increased. By examining expandable devices that have achieved commercial success and exploring emerging innovations, we aim to offer an in-depth evaluation of the different types of expandable cages used in spine surgery and the underlying mechanisms that drive their functionality.Areas covered: We performed a review of expandable spinal implants and devices by querying the National Library of Medicine MEDLINE database and Google Patents database from 1933 to 2024. Five major types of mechanical jacks that drive expansion were identified: scissor, pneumatic, screw, ratchet, and insertion-expansion.Expert opinion: We identified a trend of screw jack mechanism being the predominant machinery in vertebral body reconstruction cages and scissor jack mechanism predominating in interbody cages. Pneumatic jacks were most commonly found in kyphoplasty devices. Critically reviewing the mechanisms of expansion and identifying trends among effective and successful cages allows both surgeons and medical device companies to properly identify future areas of development.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140338260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The realization of medical devices for precision surgery - development and implementation of 'stop-and-go' imaging technologies. 实现精准外科手术的医疗设备--开发和实施 "即停即走 "成像技术。

Expert review of medical devices Pub Date : 2024-05-01 Epub Date: 2024-05-09 DOI: 10.1080/17434440.2024.2341102

Fijs W B van Leeuwen, Tessa Buckle, Daphne D D Rietbergen, Matthias N van Oosterom

{"title":"The realization of medical devices for precision surgery - development and implementation of 'stop-and-go' imaging technologies.","authors":"Fijs W B van Leeuwen, Tessa Buckle, Daphne D D Rietbergen, Matthias N van Oosterom","doi":"10.1080/17434440.2024.2341102","DOIUrl":"10.1080/17434440.2024.2341102","url":null,"abstract":"Introduction: Surgery and biomedical imaging encompass a big share of the medical-device market. The ever-mounting demand for precision surgery has driven the integration of these two into the field of image-guided surgery. A key-question herein is how imaging modalities can guide the surgical decision-making process. Through performance-based design, chemists, engineers, and doctors need to build a bridge between imaging technologies and surgical challenges.Areas-covered: This perspective article highlights the complementary nature between the technological design of an image-guidance modality and the type of procedure performed. The specific roles of the involved professionals, imaging technologies, and surgical indications are addressed.Expert-opinion: Molecular-image-guided surgery has the potential to advance pre-, intra- and post-operative tissue characterization. To achieve this, surgeons need the access to well-designed indication-specific chemical-agents and detection modalities. Hereby, some technologies stimulate exploration ('go'), while others stimulate caution ('stop'). However, failing to adequately address the indication-specific needs rises the risk of incorrect tool employment and sub-optimal surgical performance. Therefore, besides the availability of new technologies, market growth is highly dependent on the practical nature and impact on real-life clinical care. While urology currently takes the lead in the widespread implementation of image-guidance technologies, the topic is generic and its popularity spreads rapidly within surgical oncology.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140900777","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Anterior segment swept-source optical coherence tomography and ultrasound biomicroscopy in iris and ciliary body lesions. 虹膜和睫状体病变的前段扫源光学相干断层扫描和超声生物显微镜。

Expert review of medical devices Pub Date : 2024-05-01 Epub Date: 2024-05-27 DOI: 10.1080/17434440.2024.2344668

Ibadulla Mirzayev, Ahmet Kaan Gündüz, Ömür Özlenen Gündüz, Funda Seher Özalp Ateş, Aylin Okcu Heper

{"title":"Anterior segment swept-source optical coherence tomography and ultrasound biomicroscopy in iris and ciliary body lesions.","authors":"Ibadulla Mirzayev, Ahmet Kaan Gündüz, Ömür Özlenen Gündüz, Funda Seher Özalp Ateş, Aylin Okcu Heper","doi":"10.1080/17434440.2024.2344668","DOIUrl":"10.1080/17434440.2024.2344668","url":null,"abstract":"Objectives: Differentiation of iris and ciliary body lesions as benign or malignant and cystic or solid is important. The aim of this study was to compare anterior segment swept-source optical coherence tomography (AS SS-OCT) and ultrasound biomicroscopy (UBM) findings in iris and ciliary body tumors.Research design and methods: Forty-two eyes of 38 cases with iris and ciliary body tumors imaged with UBM and AS SS-OCT between September 2018 and September 2023 were evaluated retrospectively.Results: Of 42 eyes, 14 had melanoma, 14 iris pigment epithelial (IPE) cysts, 7 nevi, 3 Lisch nodules, 2 iris stromal cysts, 1 pars plana cysts, and 1 iris mammillations. An equivalent (100%) visualization of the anterior tumor margin was obtained with both techniques. Compared to AS SS-OCT, UBM was superior for posterior margin visualization in melanocytic tumors and IPE cysts. Bland-Altman plots demonstrated good agreement between UBM and AS SS-OCT for melanocytic tumors < 2.5 mm in base diameter and < 2 mm in thickness.Conclusions: Although, UBM is the gold standard for ciliary body and iridociliary tumors. AS SS-OCT should be considered as an excellent alternative to UBM, especially in minimally elevated iris lesions.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141159296","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Echocardiography in the neonatal unit: current status and future prospects. 新生儿病房的超声心动图：现状与前景。

Expert review of medical devices Pub Date : 2024-04-01 Epub Date: 2024-03-25 DOI: 10.1080/17434440.2024.2334449

Yogen Singh

{"title":"Echocardiography in the neonatal unit: current status and future prospects.","authors":"Yogen Singh","doi":"10.1080/17434440.2024.2334449","DOIUrl":"10.1080/17434440.2024.2334449","url":null,"abstract":"Introduction: Traditionally echocardiography was used by pediatric cardiologists to diagnose congenital heart defects in neonates. Formalized neonatal hemodynamic fellowships have been established where neonatologists acquire advanced echocardiographic skills to gain anatomical, physiological, and hemodynamic information in real time and utilize this information in making a timely and accurate physiology-based clinical decision.Area covered: Differences between a comprehensive formal structural echocardiography, neonatologist performed targeted echocardiography and limited assessment on point-of-care-ultrasonography for specific indications have been covered. This article is focused at providing a comprehensive review of the status of echocardiography in the neonatal units, recent advancements and its future prospects in the neonatal intensive care units.Expert opinion: Comprehensive guidelines providing the scope of practice, a framework for training, and robust clinical governance process for the neonatologist performed targeted echocardiography have been established. In the last decade, echocardiography has emerged as essential vital bedside diagnostic tool in providing high-quality care to the sick infants in the neonatal units, and it has proved to improve the outcomes in neonates. It is now being considered as a modern hemodynamic monitoring tool. Advances in technology, machine learning, and application of artificial intelligence in applications of echocardiography seem promising adjunct tools for rapid assessment in emergency situations.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140208713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Navigating hypotony challenges with XEN gel implantation. 通过 XEN 凝胶植入术应对骨盆下垂的挑战。

Expert review of medical devices Pub Date : 2024-04-01 Epub Date: 2024-03-07 DOI: 10.1080/17434440.2024.2327529

Khaled A Elubous

{"title":"Navigating hypotony challenges with XEN gel implantation.","authors":"Khaled A Elubous","doi":"10.1080/17434440.2024.2327529","DOIUrl":"10.1080/17434440.2024.2327529","url":null,"abstract":"Introduction: The XEN Gel, a hydrophilic tube meticulously crafted to adhere to the principles of the Hagen - Poiseuille law, is designed to facilitate efficient aqueous shunting without inducing hypotony. Implantable ab interno or ab externo, with or without conjunctival opening, the device shows no significant outcome differences. Despite numerical hypotony signaling failure, patients may fare well below 6 mmHg.Areas covered: This review provides insights into device variability, challenges related to hypotony, associated risk factors, and hypotony management.Expert opinion: The progressive evolution of the XEN Gel constitutes a significant advancement in the field of glaucoma management. Comparative studies investigating diverse implantation methodologies, particularly the ab interno and closed conjunctival approaches, highlight the device versatility in addressing individual patient needs. Exploring hypotony from both statistical and clinical perspectives challenges the traditional view of intraocular pressure as a straightforward success or failure indicator. The incidence of hypotony-related issues varies between device models, emphasizes the need for an individualized approach during device selection. Overall, understanding the dynamics of hypotony is crucial for optimizing the outcomes of XEN Gel implantation.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140061596","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Medical device regulation in vascular ageing assessment: a VascAgeNet survey exploring knowledge and perception. 血管老化评估中的医疗器械监管：VascAgeNet 调查，探索知识和观念。

Expert review of medical devices Pub Date : 2024-04-01 DOI: 10.1080/17434440.2024.2334931

Maria Raffaella Martina, Chloe Park, Jordi Alastruey, Rosa Maria Bruno, Rachel Climie, Soner Dogan, Bilge Guvenc Tuna, Ana Jerončić, Marjan Manouchehri, Andrie G Panayiotou, Silvia Tamarri, Dimitrios Terentes-Printzios, Marisa Testa, Areti Triantafyllou, Christopher C Mayer, Elisabetta Bianchini

{"title":"Medical device regulation in vascular ageing assessment: a VascAgeNet survey exploring knowledge and perception.","authors":"Maria Raffaella Martina, Chloe Park, Jordi Alastruey, Rosa Maria Bruno, Rachel Climie, Soner Dogan, Bilge Guvenc Tuna, Ana Jerončić, Marjan Manouchehri, Andrie G Panayiotou, Silvia Tamarri, Dimitrios Terentes-Printzios, Marisa Testa, Areti Triantafyllou, Christopher C Mayer, Elisabetta Bianchini","doi":"10.1080/17434440.2024.2334931","DOIUrl":"10.1080/17434440.2024.2334931","url":null,"abstract":"Background: Regulation has a key role for medical devices throughout their lifecycle aiming to guarantee effectiveness and safety for users. Requirements of Regulation (EU) 2017/745 (MDR) have an impact on novel and previously approved systems. Identification of key stakeholders' needs can support effective implementation of MDR improving the translation to clinical practice of vascular ageing assessment. The aim of this work is to explore knowledge and perception of medical device regulatory framework in vascular ageing field.Research design and methods: A survey was developed within VascAgeNet and distributed in the community by means of the EUSurvey platform.Results: Results were derived from 94 participants (27% clinicians, 62% researchers, 11% companies) and evidenced mostly a fair knowledge of MDR (despite self-judged as poor by 51%). Safety (83%), validation (56%), risk management (50%) were considered relevant and associated with the regulatory process. Structured support and regulatory procedures connected with medical devices in daily practice at the institutional level are lacking (only 33% report availability of a regulatory department).Conclusions: Regulation was recognized relevant by the VascAgeNet community and specific support and training in medical device regulatory science was considered important. A direct link with the regulatory sector is not yet easily available.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140338259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions. 使用新一代双支和三支内植物血管重建主动脉弓：设计、适用性、适应症、结果和未来方向。

Expert review of medical devices Pub Date : 2024-04-01 DOI: 10.1080/17434440.2024.2337920

Ciro Ferrer, Giovanni Tinelli, Mario D'Oria

{"title":"Endovascular reconstruction of the aortic arch with new-generation dual-branch and triple-branch endograft: design, applicability, indications, outcomes, and future directions.","authors":"Ciro Ferrer, Giovanni Tinelli, Mario D'Oria","doi":"10.1080/17434440.2024.2337920","DOIUrl":"https://doi.org/10.1080/17434440.2024.2337920","url":null,"abstract":"Introduction: Repair of aortic arch pathologies such as degenerative aneurysms and dissections still represents a significant challenge for vascular and cardiac surgeons. We focused on the design, evolution, implementation, and prospects of endovascular dual branch technology for treatment of pathologies in the aortic arch.Areas covered: The literature search was conducted in a non-systematic fashion through the PubMed and Scopus databases; articles deemed relevant to the scope of the work and fully published in English language from January 12,000 until December 2023 were considered for inclusion. Two companies so far have developed and launched in market a dedicated arch dual branch platform: Terumo Aortic and Cook Medical.Expert opinion: A common limitation to the available technology is represented by the fact that urgent cases (i.e. large or rapidly growing aneurysms, symptomatic patients) cannot be treated because the customization process generally takes between 6 and 8 weeks, and there is an inherent risk for aorta-related adverse events to happen during the waiting time. While the future holds much promise, several technical hurdles still exist and further developments (in device design, operators' skills, patients' selection, and outcomes assessment) are needed to establish the safety and effectiveness of treatment particularly over the long-run.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140338258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Which way forward? Comparing radiological outcomes using three different surgical approaches in robotic assisted total hip arthroplasty. 何去何从？比较机器人辅助全髋关节置换术中三种不同手术方法的放射学效果。

Expert review of medical devices Pub Date : 2024-04-01 Epub Date: 2024-03-29 DOI: 10.1080/17434440.2024.2334932

Zhang Xianzuo, Shen Xianyue, Abasi Maimaitiabula, Zhang Zian, Zhang Haining, Yang Bo, Zhu Chen

{"title":"Which way forward? Comparing radiological outcomes using three different surgical approaches in robotic assisted total hip arthroplasty.","authors":"Zhang Xianzuo, Shen Xianyue, Abasi Maimaitiabula, Zhang Zian, Zhang Haining, Yang Bo, Zhu Chen","doi":"10.1080/17434440.2024.2334932","DOIUrl":"10.1080/17434440.2024.2334932","url":null,"abstract":"Objectives: To assess the accuracy and precision of acetabular component placement in robot-assisted surgery total hip arthroplasty (RAS-THA) using three different approaches.Methods: This study is a secondary analysis from a multicenter, randomized controlled trial comparing the Trex RS Hip 1.0 robot navigation system across different surgical approaches. It involved 145 patients treated at three Chinese medical centers from June 2021 to July 2022. Patients with end-stage joint disease were randomly assigned to either the RAS or control group. Acetabular component positioning was evaluated radiographically, and registration accuracy was measured using Root Mean Square Error (RMSE).Results: The overall RMSE was 0.72 mm (SD = 0.24 mm), indicating consistent accuracy regardless of surgical approach. Significant variations in anteversion were noted across groups (p = 0.001). Lateral RAS-THA showed enhanced precision. The RAS Direct Anterior Approach (DAA) group had the least deviation in the rotation center's horizontal distance (0.89 ± 1.14 mm, p = 0.0014) and minimal leg length discrepancy (2.41 ± 1.17 mm). The RAS DAA approach also produced more consistent results.Conclusion: Robotic assistance in THA, especially via the DAA approach, enhances the accuracy and precision of acetabular component positioning. Consistent registration accuracy across various surgical approaches confirms the reliability of these methods for THA.Clinical trial registration: www.clinicaltrials.gov identifier is ChiCTR2100044124.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140320189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of clinical outcomes and prognosis of patients with early bronchogenic lung cancer after treatment of rigid bronchoscopy combining fiberoptic bronchoscopy: a single-center retrospective study. 分析早期支气管肺癌患者接受硬质支气管镜和纤维支气管镜联合治疗后的临床疗效和预后：一项单中心回顾性研究。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-01-04 DOI: 10.1080/17434440.2023.2298711

Zhengbing He, Juhua Hou, Yong Li, Yu Li, Wei Zeng, Wenguang Liu

{"title":"Analysis of clinical outcomes and prognosis of patients with early bronchogenic lung cancer after treatment of rigid bronchoscopy combining fiberoptic bronchoscopy: a single-center retrospective study.","authors":"Zhengbing He, Juhua Hou, Yong Li, Yu Li, Wei Zeng, Wenguang Liu","doi":"10.1080/17434440.2023.2298711","DOIUrl":"10.1080/17434440.2023.2298711","url":null,"abstract":"Objectives: To investigate the clinical value of rigid bronchoscopy combined with fiberoptic bronchoscopy in patients with early bronchogenic lung cancer who underwent sleeve lobectomy.Methods: A retrospective study was performed on 76 patients with early bronchogenic lung cancer admitted to our center from March 2016 to March 2017. Patients in the control group received conventional sleeve lobectomy (n = 38), while patients in the observation group underwent sleeve lobectomy by using rigid bronchoscopy combining fiberoptic bronchoscopy (n = 38). We compared perioperative period indicators and the recovery of pulmonary function indexes one month after the operation were compared in two groups. The prognosis of the patients were also analyzed.Results: Compared with the control group, the intraoperative blood loss, operation duration and airway reconstruction duration in the observation group were significantly reduced. The total incidence of perioperative complications was markedly lower in the observation group than in the control group. The percentage of DLCO% was significantly improved in the observation group. The relapse-free survival (RFS) in the observation group was remarkably longer than in the control group.Conclusion: Rigid bronchoscopy combined with fiberoptic bronchoscopy is beneficial to improve the clinical outcome and prognosis of patients with early bronchogenic lung cancer more effectively.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138833687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Thoraflex Hybrid Prosthesis (THP): the profile. Thoraflex混合假体（THP）：简介。

Expert review of medical devices Pub Date : 2024-03-01 Epub Date: 2024-03-05 DOI: 10.1080/17434440.2024.2326539

Matti Jubouri, Fatima Kayali, Tiffany Agbobu, Owais Tahhan, Thurkga Moothathamby, Eyad R Abdulwahab, Bashi Velayudhan, Idhrees Mohammed, Mohamad Bashir

{"title":"Thoraflex Hybrid Prosthesis (THP): the profile.","authors":"Matti Jubouri, Fatima Kayali, Tiffany Agbobu, Owais Tahhan, Thurkga Moothathamby, Eyad R Abdulwahab, Bashi Velayudhan, Idhrees Mohammed, Mohamad Bashir","doi":"10.1080/17434440.2024.2326539","DOIUrl":"10.1080/17434440.2024.2326539","url":null,"abstract":"Introduction: With the incidence of thoracic aortic disease on the rise, total arch replacement (TAR) with frozen elephant trunk (FET) remains the gold-standard management strategy due to optimal results. Several FET devices exist commercially on the global market. However, the mainstay and most commonly used and reported device is the Thoraflex Hybrid Prosthesis (THP), with several recent reports suggesting its superiority.Areas covered: This review aims to collate and summarize the evidence in the literature on the clinical outcomes of TAR with FET using THP, with a focus on mortality, neurological complications, endoleak, distal stent-induced new entry (dSINE), aortic remodeling, coagulopathy, and graft kinking. In addition, the design features of THP is discussed, and an overview of market competitors is also highlighted.Expert opinion: THP consistently demonstrates its effectiveness in treating complex thoracic aortic pathology through favorable clinical outcomes, which can be attributed to its unique and innovative design. Rates of early mortality ranged 0.6-14.2%, neurological complications 0-25%, endoleak 0-8.4% and dSINE 0-14.5%, with minimal incidence of graft kinking and coagulopathy. Aortic remodeling is favorable and comparable to competitors. All this evidence solidifies THP as the leading FET device, particularly when combined with appropriate patient selection and surgical planning.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140023811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0