Tricuspid regurgitation (TR): an overview
TR occurs when the tricuspid valve, which regulates the blood flow between the right atrium and right ventricular chamber, fails to close properly. This causes blood to flow backwards into the right atrium.
TR is a serious cardiac condition affecting over 1.6 million patients in the US and over 3 million in Europe. Although TR is a common condition, it has been underestimated and neglected for many years, leading to a significant number of untreated patients.
There is growing evidence that untreated TR has a significant impact on long-term survival and quality of life for patients. Yet there are clear limitations to current approaches.
The need for an innovative, minimally invasive approach
Open-heart surgery has been the standard treatment option for repairing or replacing insufficient valves alongside medical treatments. However, with surgical mortality rates ranging from 10% to 35%, the vast majority of TR patients are deemed ineligible for curative surgeries.
Instead, high-risk patients are maintained on pharmacological treatment alone, leading to a poor prognosis with a median survival of 2.2 years.
There has been some progress has been made with newer, lower-risk approaches to TR. These include a new generation of repair devices. However, results to date have been inconsistent.
Given these challenges, cardiac surgeons and interventional cardiologists have long been waiting for a minimally-invasive, transcatheter-based solution to treat patients suffering with severe TR and improve clinical outcomes.
TRiCares is seeking to address this unmet need with the Topaz system.
Therefore, physicians are urgently seeking minimally-invasive, low-risk solutions to improve clinical outcomes in TR patients with no other viable treatment option.
TR medical need
at a glance
Significant global patient population
TR affects over 1.6 million in the US and over 3 million in Europe.
Short life expectancy
Patients suffering from severe TR face a dramatically reduced life expectancy. Without intervention there is a 40% mortality rate of within 4 years of diagnosis. (reference)
Surgical intervention too high risk
Traditional surgical intervention for TR is associated with high mortality rates, between 10% and 35%, leaving many patients ineligible for surgery.
Technical challenges
Recent advancements in transcatheter repair devices have shown to be effective but are associated with a long intervention time, as well as inconsistent and disappointing, due to the complexity of heart anatomies.
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
Implantable through established pathways: transfemoral and transjugular [veins]
Fabricated using state of the art biological heart valve material
The first tricuspid replacement device developed in Europe