Moderate to severe mitral regurgitation is one of the most frequent structural heart valve diseases. Its prevalence increases with age at 2-3% in adult population, millions of patients are at risk in the US and EU.
For decades, open-heart surgery has been the only available treatment for this disease. Normally, the mitral valve closes when the left ventricle contracts, preventing blood from flowing backwards into the left atrium. MR occurs when the valve fails to seal. Patients with MR suffer from severe symptoms, including difficulty breathing, heart failure, and even increased mortality. Until recently up to 40% of patients with severe MR were excluded from treatment due to advanced age or comorbidities. Furthermore, there is still no therapeutic treatment option for asymptomatic patients with severe MR. In total, the target market volume in key Western markets is approx. € 2 bn p.a. (EU, USA, Japan).
Promising Solution: mitramaze® valve repair system – Technological background
To address this high medical need, coramaze technologies focuses on developing its mitramaze® valve repair system to allow for a minimally invasive transcatheter implantation into the beating heart.
The mitramaze® valve repair system is being developed with the following design features:
- A low profile delivery catheter system for a transfemoral arterial access route for positioning and implant deployment
- Atraumatic anchoring within the left atrium
- A fillable balloon spacer for an optimal coaptation of valve leaflets without injury to adjacent tissue structure.
- Implant retrievable and repositionable prior to full deployment.
Promising pre-clinical animal data support the development from a design concept into a clinical prototype for a first-in-human clinical trial expected to enroll in 2020.