Mitral Valve Disease

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Overview Mitral valve disease takes many different forms: mitral valve prolapse, annular enlargement, leaflet tethering, papillary muscle extension and leaflet tearing (see Fig. 1). All of these conditions result in leakage of the valve in its closed position, i.e. mitral regurgitation (MR), which can lead to heart failure. We are developing an easy to implant device that will treat MR in patients with moderate to severe mitral valve disease. Clinical Need & Potential Market - Statistical Overview - Incidence of valvular heart disease in the US is approximately 2.5% of the population [Nkomo et al Lancet 2006] - Mitral valve disease (MVD) is the most common form of heart valve disease consisting of 1.7% of the 2.5% - Approximately 3.5 million American citizens currently have mitral valve disease [Nkomo et al Lancet 2006] - Mortality rate during the surgical procedure for patients over the age of 75 is approximately 25% [Rajendra et al Ann Thor Surg 2002] - Approximately 9% of US citizens over the age of 75 have mitral valve disease [Marelli et al Circ 2007] - UN population prospects indicate that the number of people aged over 75 in the developed world is estimated to increase by 40% in the period between 2000 and 2020 [UN World Population Prospects: The 2008 Revision] - The transcatheter mitral valve market is approximately a $1-2Bn opportunity Similar Device Example MitraClip – Evalve Inc. This device uses a barbed clip to attach the anterior and posterior leaflet edges in an effort to treat MR (see Fig. 2). It is a transcatheter based device, which is delivered through the venous system and across the atrial septal wall to the mitral valve (MV). The technology was acquired by Abbott Vascular in 2009 for $400m. MitraClip Limitations: - Based on a moderately successful surgical procedure - Complex delivery system - Implantation technically challenging - Potentially prolonged surgical time. Device Concept Our concept is a transcatheter based device for the treatment of a diseased Mitral Valve (MV), used for both MV repair and replacement. Advantages Over Other Existing Devices - Simple transcatheter delivery system - Faster, safer and less invasive than traditional MV surgery - Straightforward anchoring, placement and deployment technology - Partial or total MV treatment - Reliable system for fastening the device in place - Reduced surgical time/ patient recovery time. Patent Status The priority date on this technology is Jan 2011, whereby a European Patent application was filed. Presently the inventive step and novelty arguments are progressing and current feedback is very positive.