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Transcatheter Mitral Valve Replacement: Functional Requirements for Device Design, Bench-Top, and Pre-Clinical Evaluation

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Abstract

Transcatheter Mitral Valve Replacement (TMVR) is currently under clinical investigation as a viable treatment option for mitral regurgitation (MR). Therefore, it is important to outline the key functional requirements of a TMVR prosthesis in order to provide an overall approach to assessing mitral valve replacement devices utilizing a combination of in vitro and preclinical methods. This article provides a review of the mitral valve disease as well as general considerations and guidance for developing a TMVR device based on International Industry Standards. Specific details pertaining to the mitral valve apparatus, morphology of mitral valve disease, assessment of specific patient population as well as hazard analysis to evaluate and develop a TMVR device to treat a specific patient population have been included. The details contained within this report are not all inclusive or explicate for every technology being developed but rather thought of as a general guide on how a TMVR technology could be developed in alignment with International Industry Standards. Key learnings from the Transcatheter Aortic Valve Replacement (TAVR) experience has also been considered and taken into account when outlining this general guidance for TMVR. Key learning points from the TAVR development experience included the following: quantification of acceptable levels of paravalvular leak, valve migration potential using various anchoring methods and overall implant frame failure modes when treating the native aortic valve. It should be noted that TAVR is over a decade further along in development and clinical experience compared to TMVR. These key learnings from the early experience with TAVR should be considered with all transcatheter development projects.

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Research Involving Human Participants and/or Animals

This article does not contain any studies with human participants or animals performed by any of the authors. This manuscript was created to provide guidance on conducting example studies but no actual data was included within.

Author information

Authors and Affiliations

  1. LivaNova PLC, Maple Grove, MN, USA

    Ramji Iyer

  2. Neovasc Inc., Richmond, BC, Canada

    Aaron Chalekian & Randy Lane

  3. Abbott Laboratories, St. Paul, MN, USA

    Mike Evans

  4. Edwards Life Sciences, Irvine, CA, USA

    Seung Yi

  5. Medtronic, Redwood City, CA, USA

    John Morris

Authors
  1. Ramji Iyer
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  2. Aaron Chalekian
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  3. Randy Lane
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  4. Mike Evans
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  5. Seung Yi
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  6. John Morris
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Corresponding author

Correspondence to Aaron Chalekian.

Additional information

Associate Editor Ajit P. Yoganathan oversaw the review of this article.

Appendix A1: Example—Device Product Development

Appendix A1: Example—Device Product Development

Table A1 Degenerative and functional mitral regurgitation (primary and secondary MR): overall device key considerations: disease state for treatment, patient screening, treatment population (age range), labeled size and use range of device.
Full size table

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Iyer, R., Chalekian, A., Lane, R. et al. Transcatheter Mitral Valve Replacement: Functional Requirements for Device Design, Bench-Top, and Pre-Clinical Evaluation. Cardiovasc Eng Tech 9, 301–338 (2018). https://doi.org/10.1007/s13239-018-0364-z

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  • DOI: https://doi.org/10.1007/s13239-018-0364-z

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