CardioSolutions Mitra-Spacer TM A Novel Approach to Mitral - - PowerPoint PPT Presentation

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CardioSolutions Mitra-Spacer TM A Novel Approach to Mitral - - PowerPoint PPT Presentation

CardioSolutions Mitra-Spacer TM A Novel Approach to Mitral Regurgitation Jian Ye, MD, FRCSC Division of Cardiac Surgery St. Pauls Hospital University of British Columbia Vancouver, Canada Disclosure Statement of Financial Interest I, Jian Ye


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Jian Ye, MD, FRCSC

Division of Cardiac Surgery

  • St. Paul’s Hospital

University of British Columbia Vancouver, Canada

CardioSolutions Mitra-SpacerTM

A Novel Approach to Mitral Regurgitation

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SLIDE 2

Disclosure Statement of Financial Interest

I, Jian Ye, DO NOT have a financial interest/arrangement or affiliation with one

  • r more organizations that could be

perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

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Minimally-Invasive MV Repair Technologies

  • Leaflet Coaptation

 Edge-to-Edge Repair  Alfieri Stitch

  • Annular Reshaping

 Cinching  Annuloplasty

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Cardiosolutions Mitra-SpacerTM

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In Vitro Study

Cardiosolutions Spacer Boundary Condition Characterization

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In Vitro Study

Cardiosolutions Spacer Boundary Condition Characterization

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Acute and Chronic Animal Study

Transapical Approach

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Chronic Animal Study

Patchy mild granularity of surface of anterior leaflet (predominately affecting A2 and A3), and mild endocardial fibrosis of the left atrium above P3 after 391 days

Anter ior Leafl et Poste rior Leafl et

P 1 P 2 P 3 A 1 A 2 A 3

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Percutaneous approach (acute study)

Figure 7. Implant deployed Apex of LV Left atrium Balloon spacer Anchor hooks deployed into tissue Cusps of mitral valve

Clinical Feasibility Study

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Before the Spacer After the Spacer

Clinical Feasibility Study

Percutaneous Approach (acute study)

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Transapical Approach (acute study)

Clinical Feasibility Study

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Transapical Approach (acute study)

Before Mitra-Spacer After

Clinical Feasibility Study

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Potential Advantages of Mitra-Spacer™

  • Safe, fast, intuitive procedure
  • Small access portals
  • Percutaneous or transapical approaches
  • No change in the native mitral valve and heart

anatomy after short-term implantation

  • Minimal alterations in mitral structure following

long-term implantation – does not preclude patients from subsequent surgical MV repair

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SLIDE 14

Potential Indications

  • Functional MR
  • High surgical risk patients with either

functional or structural MR Long term or bridge therapy

  • Non-surgical patients with either functional
  • r structural MR

Long term therapy (Permanent solution?)

  • MR patients undergoing other transcatheter

procedures

  • TAVR: patient with AS and MR
  • PCI: patient with CAD and MR
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