Clinical Rational

Since the 1980s, the introduction of catheter based therapies such as balloons and stents became the dominant technologies over other conventional surgical approaches for the treatment of coronary artery disease creating a $10 Billion+ market over the next 30 years. The same trend is now starting in Valve Surgery.

Percutaneous replacement of the aortic valve has been demonstrated in clinical trials to be a valid alternative to the conventional aortic surgery among patients with aortic stenosis at high risk for surgery. Due to its high grade of biological complexity and surgical risk, mitral valve regurgitation (MR) is considered to be the next big frontier in the device development field.

  • Mitral Valve regurgitation (MR) is the most common type of heart valve insufficiency and 4,000,000 people in the USA suffer from this condition. 250,000 new diagnoses are made each year.
  • MR consists of 2 different patients population: degenerative and functional (Figure 1).
    • In the degenerative MR (prevalence is 2 million patients worldwide) the mitral valve has a physical deformity due to congenital or rheumatic disease. MR replacement should be considered when the valve apparatus itself is too damaged or out-of-plane to warrant repair.
    • In the functional MR (prevalence is 5 million patients worldwide) the dilated heart stretches open the mitral valve causing it to leak or regurgitate. Goal would be to use a technology that does not limit future clinical options.
  • Surgery for MR is vastly underpenetrated (50,000/ yr in USA). Between 30 % to 50% of patients with severe, symptomatic MR are non-candidates for conventional surgical valve replacement. Impaired LVEF, older age, and comorbidities are the most striking characteristics of patients denied for surgery.
  • The magnitude of patients eligible for percutaneous for mitral replacement is significantly larger than the aortic valve: 3.6MM Mitral vs. 240,000 Aortic (AS) in US alone. Similar numbers in Europe