What is the medical need?

Tricuspid heart valve regurgitation (TR) is a serious cardiac condition affecting more than 1.8 million patients in USA. For patients with severe TR ideal technological solutions have been looking for a long time, due to anatomic, functional and technological challenges. 

Consequently, open-heart surgery has been the standard treatment options during the last decades to repair or replace the insufficient valve and medical treatments. Due to excessive acute mortality rates (10–35 % surgical mortality), the vast majority of TR patients are considered ineligible for curative surgeries and are only maintained on pharmacological treatment, with a subsequent poor prognosis (2.2 years median survival). Therefore, minimally invasive, low-risk solutions to improve clinical outcomes in TR patients are likely to become the standard of care. 

Therefore, physicians are urgently seeking minimally-invasive, low-risk solutions to improve clinical outcomes in TR patients with no other viable treatment option.


Other Medical 
Need Comments

huge market worldwide

Tricuspid regurgitation is a huge market worldwide. Within the United States of America, at least 1.8 million people suffer from this desease

short life expectancy

Untreated patients with severe tricuspid regurgitation have a short life expectancy: 40% die within 4 years if there is no help (reference)

10% mortality

Because of the high acute mortality risk (approximately 10%) with surgical treatment, many patients are left untreated

long intervention time

The recent introduction of transcatheter repair devices has shown to be effective but time consuming (long intervention time). In addition, the results are frequently disappointing due to complex anatomies with large coaptation gaps and/or transtricuspid placed pacemaker leads. Hence, a simple fast and effective solution would be desirable.

Support Arguments  
for Device Description

Topaz is the first in Europe developed tricuspid replacement device.

Topaz is designed to eliminate tricuspid regurgitation (TR) with a minimal invasive procedure – easy and fast

State of the art biological heart valve material used

The unique design is the result of a French/German co-development. 

Topaz is a two-in-one stent design for optimal treatment of tricuspid regurgitation