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The Leaflex™ Performer is an investigational device

European Union: CAUTION Exclusively for Clinical Investigation

Clinical Studies

First-In-Human Study 

Objective

Results

The study was aimed at assessing the safety and acute performance of the scoring mechanism of action in patients undergoing surgical aortic valves replacement immediately before valve excision and replacement.

Methods

  • In the lack of blood flow during open heart surgery, valve resistance to flow (and thus the effect of scoring) was assessed by pulling a measuring tool across the valve using a force gauge pre and post scoring.

  • The peak pull-out force is correlative to the transvalvular pressure gradient across the valve, i.e., to valve resistance to blood flow through it. This correlation allowed to estimate the pressure gradient post treatment using the echo based baseline pressure gradient.

  • The estimated aortic valve area was calculated using the Gorlin formula both pre and post treatment.

  • No damage to the valve surrounding structures

  • No increase in aortic regurgitation

  • No damage to the ventricular tissue and no leaflet tears

  • Multiple scoring lines in the calcium deposits on the aortic aspect of the leaflets

  • Significant improvement in estimated transvalvular pressure gradient and aortic valve area.

Conclusion

The study results show that the scoring mechanism of action in the intra-operative clinical setting is feasible, where scoring was performed as planned, did not result in damage to the valve or its surrounding, and showed improvement in estimated aortic valve area and pressure gradient post treatment.

Case Study

The study was aimed at assessing the safety, feasibility and acute performance of the Leaflex™ in patients undergoing transfemoral aortic valve replacement

* Pre Leaflex™ - echo based pressure gradient and aortic valve area. Post Leaflex™ - estimated pressure gradient and aortic valve area based on the Gorlin formula

Pre Leaflex

Post Leaflex

Pre Leaflex

Post Leaflex

Trans-femoral Feasibility Study

Objective

The study was aimed at assessing the safety, feasibility and acute performance of the Leaflex™ in patients undergoing transfemoral aortic valve replacement

Procedure Flow

Introduction

Unsheathing

Positioning

Scoring

Sheathing

Case Study

Patient Baseline Characteristics

  • 81 y/o Male

  • Hypertension

  • Diabetes

  • Stable angina

  • Pulmonary hypertension

  • Severe renal impairment

  • NYHA I

  • Permanent pacemaker

Pre Leaflex

Post Leaflex

Pre Leaflex

Post Leaflex

Pre Leaflex

Post Leaflex

Pre Leaflex

Post Leaflex: Significantly Improved Leaflet Mobility