Device Description
The Topaz Transcatheter Tricuspid Valve Replacement (TTVR) System is designed to eliminate tricuspid regurgitation through a minimally invasive approach. This system consists of the Topaz Heart Valve Prosthesis and a catheter-based implantation system that flexes with every heartbeat.
It is developed exclusively for the use in the tricuspid position and to provide a system for physicians that is safe and easy to implant.
The Topaz System includes a unique two-stent valve prosthesis, inserted primarily via the femoral vein, which transports the prosthesis into the right half of the heart, before it is released to replace the diseased tricuspid valve.
Benefits/Strengths
of Topaz
Designed to eliminate tricuspid regurgitation (TR) through a minimally invasive procedure – easy and fast
Employs a two-in-one stent design for optimal treatment of TR
Simple and fast procedure (35 minutes average time reported in first-in-human trial)
Low impact on cardiac electrical conduction pathways (as demonstrated in first-in-human trial)
Two different valve sizes in development to cater to a wide patient population
Implantable through established pathways: transfemoral and transjugular veins
Topaz® Heart Valve Prosthesis
The Topaz Prosthesis is a self-expanding biological heart valve, composed of two pre-connected structural components:
An Outer Stent, anchors on the native tricuspid leaflets in an orthotopic position and adapts seamlessly to different shapes and dimensions of the patients’ anatomy.
An Inner Stent, serves as the skeleton for the three-leaflet pericardial tissue valve and is designed to ensure proper valve functionality and long-term performance.
Topaz® Implantation System
The Topaz Implantation System is designed for both transfemoral venous and transjugular access. It consists of two main elements:
1 The Steerable Sheath
For atraumatic access into the transfemoral venous vessel. By active deflection through bending wheels, a perpendicular landing onto the tricuspid annulus is achieved.
2 The Delivery System
The Delivery System is designed with an easy-to-use deployment mechanism. It facilitates the deployment of the Topaz Prosthesis to its intended final position.
