An estimated 60 million people, 20-25%, of the adult population in the United States alone are suffering from structural heart defects. These heart defects include patent forman ovale (PFO), atrial septal defect (ASD) and valvular disease. The European Union (EU), with a population in excess of 500 million inhabitants of which more than 88 million are over the age of 65, represents an even larger market for devices addressing structural heart repair.
Structural Heart Disease
The prevalence of aortic stenosis exceeds 830,000 people in the US and 1.75 million in the EU. Approximately 30% of patients receiving valve replacement for aortic stenosis in the EU are currently receiving transcatheter valves. It is estimated that the transapical closure device market will exceed $400 million by 2016.
Transapical Access and Closure:
The "Achilles Heel" of TAVR
The initial market for Permaseal™ is for those patients suffering from aortic stenosis. There are over 1.75 million people suffering from aortic stenosis in the EU alone. Of these 1.75 million people, less than 10% are currently considered operable with today’s technology due to the risk factors and complications associated with the current open heart, on-pump surgical procedures. Even though transcatheter valve technology was introduced to Europe in 2007, transcatheter (TAVR) valves already represented 30% of the valve replacements in the EU as of 2010. WW as many as 20% of these transcatheter aortic valve replacement (TAVR) patients are being treated using the transapical approach.
The development of enabling technologies such as Permaseal, as well as next generation transcatheter valves, will greatly expand the pool of patients that can and will receive life-extending and quality-of-life improving procedures such as transcatheter valve implantation so that a much higher percentage of the 1.75 million afflicted can be treated. MID projects the market opportunity for Permaseal and its next generation configuration will exceed $525M in 2019.
A simpler, more reliable approach to transapical access will increase the percentage of aortic stenosis patients receiving transcatheter valves using a transapical approach, and will also make this approach attractive for other structural heart repair procedures including mitral valve repair and replacement.
The Emergence of TAVR
Transcatheter aortic valve replacement procedures (TAVR) were approved in Europe in 2007. These procedures were approved in the United States in 2012. The catheter-based procedure is eliminating the need for bypass during aortic valve replacement.
Mitral Valve Disease
- 56% of the 5.2 failure in the United States have mitral regurgitation (MR).
- There are approximately 850,000 patients with severe MR in the US, with severe MR a contributing factor in an estimated 100,000 patient deaths per year.
- There is a $2B market opportunity for heart surgeries related to mitral valve disease.
The Emergence of TMVR
New techniques and procedures are being developed for minimally invasive, catheter-based solutions for mitral valve repair and replacement. While there are no commercially approved devices available, MID is at the forefront with new technologies in development.
MID is developing a percutaneous approach to mitral valve replacement that leverages the acquired intellectual property of Endovalve™ and the PolyCor anchoring technology of Permaseal.
The Tricuspid Valve: "The Forgotten Valve"
The patient population for tricuspid regurgitation (TR) is 1.6MM people in the United States alone. Approximately 50% of people with mitral regurgitation also have tricuspid regurgitation. 80% is functional TR. Operative mortality is 20% and morbidity is even higher. There is a large unmet clinical need for interventional TV procedures due to the unfavorable surgical risk profile of these patients.
Mitral Valve Replacement
Currently, approximately 80,000 patients undergo valve repair or valve replacement surgery each year. The majority of the over four million mitral regurgitation (MR) sufferers do not receive treatment primarily due to the risks associated with cardiopulmonary bypass and open-heart surgery. While there are a variety of minimally invasive mitral valve repair techniques either under development or in clinical use, these techniques do not offer the same benefits in terms of elimination of MR as does surgical mitral valve replacement.