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InnovHeart - Transcatheter Mitral Valve Replacement (TMVR) Systems
The Mitral Valve is a complex structure positioned between the left atrium and the left ventricle. Its function is to make unidirectional the blood flow from the left atrium to the left ventricle. The Mitral Valve can be affected by two major dysfunctions: Mitral Valve Stenosis (i.e. narrowing of the mitral valve orifice), and Mitral Valve Regurgitation (i.e. blood backflow into the left atrium).
Despite the long term clinical benefits mitral repair, most patients requiring surgery remain untreated due to:
- Invasiveness of the procedure
- Poor left ventricular function (low EF)
- Prolonged recovery
Clinical Need
Mitral regurgitation (MR) is the most common heart valve dysfunction with an estimated 3.6M sufferers in the US and the EU alone. That number is projected to climb to 4.5M patients by 2025. Surgical repair is considered the “Gold Standard” in addressing MR, yet 98% of patients remain untreated due to the invasive nature of the surgery and prolonged recovery.
Current TMVR programs are falling short due to the complex and varied pathophysiology of the mitral valve. A trans-catheter solution specifically tailored to the complex pathophysiology of the mitral valve will revolutionize the treatment for millions of patients and represents a substantial market opportunity.
Percutaneous Aortic Valve Success
TAVR/TAVI global market valued at $3.67 Billion in 2017.
Projected to reach $12.2B by 2025.
Burden of valvular heart diseases: a population-based study, Nkomo et al. – The Lancet vol.368 – 2006
