The Right Solution
for the Right Heart
Introduction
CroíValve is developing a Best-In-Class minimally invasive solution for severe Tricuspid Regurgitation (TR).
It is a clear unmet clinical need, with a significant impact on mortality, cardiovascular events and quality of life. With a prevalence greater than aortic stenosis in the population over 65 years, TR is the next structural heart opportunity.
Tricuspid Regurgitation poses unique challenges in comparison with Mitral Regurgitation and so needs a solution specifically designed to overcome these challenges.
The CroíValve DUO™ Tricuspid Coaptation Valve System is a novel approach that combines repair and replacement to provide the right solution for the right heart.
Clinical Need
A significant unmet clinical need, patients with severe TR struggle with poor quality of life, are frequently hospitalized and have a greater risk of mortality.
The patient population are mostly elderly, suffer from fatigue, limited exercise tolerance, peripheral oedema and abdominal swelling. Managing these symptoms require frequent hospitalisations and severe TR has been shown to have a 4-fold increase in mortality.
Due to significant co-morbidities, less than 1% of patients receive surgical treatment. For most patients, the only option is medical therapy to achieve temporary reduction in volume overload.
Therefore, there is a clear need for a minimally invasive treatment option. However, this solution needs to consider the unique challenges of the tricuspid valve. These challenges are the frailty of the right heart tissue, nearby critical structures, imaging difficulties and progressive nature of the disease resulting in significant annular dilation and massive or torrential TR when patients are symptomatic.
Technology
CroíValve DUO Tricuspid Coaptation Valve system is a novel approach that combines repair and replacement to provide the right solution for the right heart. The DUO System is comprised of two integrated components:
A Coaptation Valve to fill the regurgitant orifice and work in tandem with the native valve. It includes a coaptation body comprised of pericardium tissue and a prosthetic valve to support diastolic flow.
An Anchor System that connects to the Coaptation Valve and includes a support catheter that adjusts and locks the position of the Coaptation Valve. This is anchored within the SVC with a stent. This approach allows for respiratory & cardiac motion. The support catheter consists of a distal implanted section and a proximal delivery section that is disconnected and removed at the end of the procedure.
Safe
Leaves the right heart untouched
Effective
Oversized for large dilated annuli
Easy to use
Realtime feedback on efficacy and clear visibility
Treats Large Annuli
Tolerates wide anatomical variability
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