Mitralign Program Update

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Presentation transcript:

Mitralign Program Update Lutz Buellesfeld MD FSCAI FESC Department of Cardiology Bern University Hospital Switzerland

Lutz Buellesfeld, MD Consulting: Mitralign Medtronic CoreValve Edwards Lifesciences, LLC Abbott Vascular

Mitralign Direct Annuloplasty Percutaneous Annuloplasty 2 pairs of surgical pledgets delivered retrograde to posterior mitral annulus Pair distance of 10-21 mm Pledgets are plicated (pulled together) P1 P3 P2 Pledgets rapidly encapsulate into the annulus Open for future repair or replacement Customized therapy Potential for customizing number, location and plication distance to match MR and heart size Plicated Pledget Pairs P1 P3 P2 Post-procedure 3D TEE 4

The Mitralign Procedure Approximating a Kay Annuloplasty Percutaneous Repair: Plicated pledget pair Surgical Repair: Kay-Wooler Annuloplasty (1962) P1 P3 P2 P1 P3 P2 Completed repair

Mitralign Procedure Steps Wire Delivery Pledget Delivery Plication & Lock 6

Mitralign Implant Pair of pledgeted polyester sutures and a stainless steel lock

Mitralign System Components Guide catheter Crossing Wire Translation (Bident) Catheter Pledget Delivery Catheter Plication, Lock Catheter

Mitralign Procedure Pledget Delivery Catheter crossing the annulus

Mitralign Procedure Pledget Delivery Catheter crossing the annulus

Mitralign Procedure Plicate and Lock-Catheter allows for suture tensioning, lock advancement, plication and lock deployment 11

Mitralign Procedure Deployed Lock and Cutting after Successful Plication

Mitralign Procedure Final

3D TEE 21 mm bident in 6.3 cm LVIDd ventricle Pre-Procedure (3+) Post-Procedure (~Trace)

2D TEE 4.8 cm LVIDd Pre-Procedure Post-Procedure

Feasibility Study Design and Patient Population Design: Prospective, single-arm, multicenter, safety and feasibility study Patient Population: Symptomatic Patients with Functional Mitral Regurgitation Time points: Baseline, discharge, 30 day, 6 month, 12-36 months Enrollment: 26 of 36 patients completed Study sites: CAUTION: Investigational Device Only. Not approved for sale in the United States

Results: Interim Echo Data Analysis MR Patients with Reduction of MR and Two Pairs Implanted Grade of MR Pre 30d 180d 365d

Results: Interim Echo Data Analysis LV Dimensions Baseline 30 D 6M 12M Baseline 30 D 6M 12M Baseline 30 D 6M 12M Baseline 30 D 6M 12M 6 month timepoint n=10, 12-month timepoint n=5

Mitralign Regulatory Status Feasibility Study Expanded Use Study CE Mark CE Marking Strategy: Target enrollment completion: Q2 2013 US Strategy: Feasibility Study commencement: Targeted 2013 + =

Conclusions Mitralign annuloplasty with the new BIDENT System is a safe and feasible procedure Mitralign annuloplasty has the potential to reduce FMR, inducing a reverse LV remodeling and improving clinical symptoms Early results are promising and further studies are ongoing / in planning to demonstrate the efficacy of this approach

Thank you