LOTUS Edge™ Valve System

Transcatheter Aortic Valve Implant (TAVI)

ADVANCING CONTROL
Simplify your TAVI procedure with the new LOTUS Edge™ Valve System. This next generation valve advances control with simplified delivery and deployment, complete repositionability, and unmatched freedom from PVL.1-7

Key Resources

LOTUS Edge™ Valve System Specifications Sheet Safari2™ Pre-shaped Guidewire Brochure Lotus™ Introducer Set Specifications Sheet Bolt™ Direct Access Sheath Specifications Sheet LOTUS Edge™ full product animation

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Product Information

Advancing Control

Simplified Delivery & Deployment
Advanced delivery system and a more flexible catheter combine ease of use with precise control.

Complete Repositionability
Exclusive technology allows you to assess early valve function, evaluate results, and reposition at any point if needed.

Unmatched Freedom From PVL1-7
Innovative Adaptive Seal™ conforms to irregular anatomies to minimize PVL.


 

 DESCRIPTION

 SPECIFICATIONS

LOTUS Edge™ Valve System Transcatheter aortic valve prosthesis premounted on delivery system
Access Routes Transfemoral and transaortic
Deployment Design Controlled Mechanical Expansion with Depth Guard™
Valve Tissue Material Bovine pericardium
Tissue Treatment T-Guard™
Valve Frame Material Braided nitinol frame
Valve Seal Technology Adaptive Seal™
Use Single use
Delivery System Sterilization Radiation process
Valve Sterilization Chemical solution
Delivery System Minimum Length 113 cm
Guidewire Compatibility .035" (0.89 mm) super/extra stiff guidewire
Retrievability 100% retrievable prior to valve release
Repositionability 100% repositionable prior to valve release
Carton Size 96.4 cm x 50.5 cm x 9.5 cm

 


 

TAVI Accessories

Transaortic & Bolt Approved!
The LOTUS Edge™ valve has received approval for delivery via the transaortic access route, in addition to the transfemoral approach.

Bolt™ Direct Access Sheath Bolt™ Direct Access Sheath

Bolt™ Direct Access Sheath


 

Safari2™ Pre-Shaped Guidewire

CE Mark & FDA Approved
The Safari2™ Pre-Shaped Guidewire has obtained CE Mark and FDA clearance. This latest version of the Safari Guidewire further facilitates the placement of interventional devices within the heart, and is compatible for use with all TAVI/R (Transcatheter Aortic Valve Implantation/Replacement) devices. It is now available in 3 sizes, including the XS, Small, and Large curves.


 

TAVI Clinical Program

Boston Scientific is dedicated to building clinical proof to support its TAVI product portfolio, with more than six on-going or completed clinical trials around the world. The RESPOND post market registry is the most recent study, tracking real world clinical performance of the approved TAVI devices.


 

Ordering Information

VALVE SIZE

23 mm

23 mm

23 mm

Treatment Range ≥ 20 mm to ≤ 23 mm ≥ 23 mm to ≤ 25 mm ≥ 25 mm to ≤ 27 mm
Sheath Compatibility Lotus™ Introducer Set Small (LIS-S) Lotus™ Introducer Set Large (LIS-L) Lotus™ Introducer Set Large (LIS-L)

 

ORDER NUMBER (GTIN)

PRODUCT CODE

PRODUCT DESCRIPTION

UNITS

08714729940814 H749LVS230 Lotus Edge™ Valve System 23mm 1
08714729940821 H749LVS250 Lotus Edge™ Valve System 25mm 1
08714729940838 H749LVS270 Lotus Edge™ Valve System 27mm 1

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