Transcatheter Mitral Valve Repair: Growing Evidence Regarding It's Efficacy and Optimal Indication

Choi, Jah Yeon; Hong, Geu Ru

doi:10.4070/kcj.2019.0154

Cited by 2 publications

(2 citation statements)

References 12 publications

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“…This approach works fairly well as a model for pharmaceutical product development, but the development of MDs is often more unpredictable. For example, it is possible for MDs to enter into regular clinical practice with relatively little clinical evidence, the evidence being predominantly gained through actual use of the device in clinical practice [18], as opposed to a research setting [19,20]. The adaptation of the IDEAL (Idea, Development, Exploration, Assessment, Long term study) framework to medical devices [21] is another attempt to inform a continuous evidence generation for devices although the proposal is awaiting empirical implementation and fuller consideration by regulatory and HTA bodies.…”

Section: Lifecycle Evidence Generation For High-risk Medical Devices: Overview Of Different Approachesmentioning

confidence: 99%

Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective

Tarricone

Ciani

Torbica

et al. 2020

Expert Review of Medical Devices

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Introduction:The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high-risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the whole lifecycle of medical devices. In this paper we address: i) the appropriate level and timing of clinical evidence throughout the lifecycle of high-risk implantable medical devices; and ii) how the clinical evidence generation ecosystem could be adapted to optimize patient access. Areas covered: The European regulatory and health technology assessment (HTA) contexts are reviewed, in relation to the lifecycle of high-risk medical devices and clinical evidence generation recommended by international network or endorsed by regulatory and HTA agencies in different jurisdictions. Expert opinion: Four stages are relevant for clinical evidence generation: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market. Each stage has its own evaluation needs and specific studies are recommended to generate the appropriate evidence. Effective lifecycle planning requires anticipation of what evidence will be needed at each stage.

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Section: Lifecycle Evidence Generation For High-risk Medical Devices: Overview Of Different Approachesmentioning

confidence: 99%

Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective

Tarricone

Ciani

Torbica

et al. 2020

Expert Review of Medical Devices

View full text Add to dashboard Cite

show abstract

“…After a Heart Team discussion, the patient was offered the transcatheter mitral-valve repair according to recent European Society of Cardiology guidelines (Class IIb). 1) 2) 3) The first grasp was performed centrally with careful attention to grasp both leaflets (A2-P2) adequately. With a single clip, the MR was reduced from IV to III.…”

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confidence: 99%

A Case of Successful MitraClip for Severe Mitral Regurgitation with Left Ventricular Dysfunction in Korea

et al. 2020

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The patient was an 81-year-old female with medical treatment for old myocardial infarction which occurred in the middle left anterior descending artery in 1989. She had multiple admission for heart failure, with the most recent admission being associated with aggravated symptoms by low left ventricular (LV) ejection fraction with severe tricuspid regurgitation (TR) despite optimal medical therapy. Chest X-ray showed cardiomegaly with bilateral pleural effusion. As shown in Figures 1 and 2, echocardiography demonstrated a

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Transcatheter Mitral Valve Repair: Growing Evidence Regarding It's Efficacy and Optimal Indication

Cited by 2 publications

References 12 publications

Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective

Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective

A Case of Successful MitraClip for Severe Mitral Regurgitation with Left Ventricular Dysfunction in Korea

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