LOTUS Edge Technology Overview and Latest Clinical Evidence

LOTUS Edge Valve System Features and Benefits

Key features of the Lotus Valve are conserved including:

  • Complete repositionability for precise placement with the option to retrieve
  • Unmatched freedom from PVL with the innovative Adaptive Seal™   
  • Early valve function maintains hemodynamic stability
  • No rapid pacing

  

Lotus Valve Lotus Valve

 

Lotus Edge Lotus Edge Lotus One-View Locking Lotus One-View Locking

New Features of LOTUS Edge

  • Simplified delivery and deployment with a more flexible catheter and Depth Guard technology
  • Proximal profile reduction of catheter (3F – 4F)
  • >30% more trackable with a more flexible delivery catheter

Lotus Delivery System Lotus Delivery System

  • One-view locking with new radiopaque tantalum markers

1Compared to Lotus™ Valve System. Profile: Edge OS Print 91040473-01 and 91047560-01. Trackability: ER11346 LOTUS Edge n=4, Lotus n=2

 

Limited Depth of Implant with Depth Guard™ Technology

  • Anchors early during deployment
  • Minimizes interaction between valve frame and the LVOT potentially leading to lower rate of conduction disturbance
  • More predictable placement

  

Deployment with Depth Guard compared to deployment with the Lotus Valve

Deployment: Lotus Valve compared to LOTUS Edge with Depth Guard Deployment: Lotus Valve compared to LOTUS Edge with Depth Guard
Deployment: Lotus Valve compared to LOTUS Edge with Depth Guard Deployment: Lotus Valve compared to LOTUS Edge with Depth Guard

 

Early Anchoring During Deployment

Deployment: Lotus Valve compared to LOTUS Edge with Depth Guard Deployment: Lotus Valve compared to LOTUS Edge with Depth Guard

 

Minimal Depth of Valve Frame & Reduced Interaction 

Deployment: Lotus Valve compared to LOTUS Edge with Depth Guard Deployment: Lotus Valve compared to LOTUS Edge with Depth Guard

 

Lotus

LOTUS Edge

Delivery System

Pre-shaped

Flexible

Sheath

18F ID

14F / 15F ID*

Locking Verification

Multiple views

One view

Valve Sizes

23mm, 25mm, 27mm

21mm*, 23mm, 25mm, 27mm, 29mm*

CE Mark Indication

Transfemoral, Transaortic

Current indications + Bicuspid, Valve-in-Valve, Subclavian

Deployment

Controlled Mechanical

Controlled Mechanical with Depth Guard

*Not yet commercially available. Under investigation

 

Results from the LOTUS Edge Feasibility Trial

LOTUS Edge Feasibility Trial LOTUS Edge Feasibility Trial

Preliminary discharge/7-day results from the LOTUS Edge Feasibility Trial suggest that the advantages of the first-generation Lotus Valve System are conserved with the next generation LOTUS Edge Valve System with 100% technical success, 100% none or trace PVL, and low VARC events. The PPM rate of 9.5% provides an initial indication that the Depth Guard feature, which enables predictable placement, early anchoring during deployment, minimal depth of valve frame and a reduced interaction with the LVOT, may effectively reduce the PPM rate. Due to the limited size of cohort studied in the LOTUS Edge Feasibility Trial, further investigation of LOTUS Edge is ongoing. 30-day data from the LOTUS Edge Feasibility Trial is anticipated at ACC 2017.

Presented by Meredith at TCT 2016

 

REPRISE Edge Study Design

REPRISE Edge Evaluation of the Acute Performance and Safety of LOTUS Edge in a Multicenter European Study of High Risk Patients is Currently Enrolling

CMO REPRISE Edge CMO REPRISE Edge

Presented by Götberg at TCT 2016

 

View Recent Lotus Valve Clinical Data Presentations

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