CroiValve

Summary: Tricuspid Regurgitation (TR) occurs in heart failure patients, due to tricuspid annular dilation. TR is an unmet clinical need affecting 550k new patients every year. Prevalence increases with age and the prognosis is poor for affected patients. Medical therapy is ineffective and surgery is associated with high operative mortality. Less invasive therapies offer the potential for improved clinical and economic outcomes. CroíValve is a minimally invasive device to repair the tricuspid valve without needing surgery. It was designed by leading cardiologist Dr. Martin Quinn based on a detailed understanding of the clinical need. The CroíValve device sits across the native valve assisting coaptation and is held in place by a non-penetrating anchoring system. The novel anchor facilitates very simple delivery and positioning. It will improve patient outcomes and save money by reducing hospitalizations.

CroíValve’s solution is simple, safe and effective. It provides a simple procedure using conventional reproducible techniques. It’s safe as it does not use tissue penetrating anchors so is repositionable and retrievable. And it’s effective as it is sized to treat a significant regurgitant orifice area. Key Opinion Leaders have been engaged in concept assessment to ensure clinical acceptability, ease of use and effectiveness.

Need: In heart failure patients, the tricuspid valve dilates, resulting in regurgitation. TR significantly impacts mortality (4x increase at 1 year), cardiovascular events and quality of life. It affects mobility, absorption of medication, renal & kidney function resulting in long, costly hospitalizations. Surgery is too high risk, so performed in only 0.5% of cases leaving no current suitable treatment option. It is currently managed by repeated IV diuretics which only treats a symptom, not the cause.

Value: The tricuspid valve is often known as the forgotten heart valve, as surgical interventions are carried out on less than 1% of patients due to the risk involved. This means there is no suitable treatment option for these sick patients. CroiValve intends to provide them with one, resulting in benefits to patients, physicians, and our healthcare systems:

– Patients: Improved and extended quality of life

– Physicians: Safe, easy and predictable treatment using conventional techniques

– Healthcare Systems: Improved patient outcomes and reduced hospitalizations fitting within the existing infrastructure.

– Payers: Reduced peri-operative and post-operative costs