MiCardia has developed the world's first, clinically proven methodology, "Dynaplasty™", designed to optimize mitral valve repair, during and after surgery. Managing mitral regurgitation remains a significant problem for people with mitral valve disease. Left untreated or undermanaged, it can lead to more significant problems, including heart failure and death.
Currently, mitral valve regurgitation (MVR) is repaired surgically with the implantation of annuloplasty rings. However, some patients have residual MVR post surgery and for 15-20% of patients, MVR significantly returns (3+/4+) within 6-12 months.
MiCardia's Dynaplasty technology is unique and is the basis for the company's innovative devices. As illustrated in the product animations, the device can be dynamically activated to physiologically reduce the shape of the valve annulus to further enhance coaptation of the leaflets and reduce regurgitation.
The initial intra-operative product, enCor™ (animation 1), addresses the current mitral valve repair market, but is unique, in that residual mitral regurgitation can be addressed acutely, off pump on a beating heart. A clinical trial was completed in 2009, showing excellent results. enCor was awarded CE Mark in October, 2010 and the company is forecasting European sales.
The second generation, enCorSQ™ (animation 2), will begin a small clinical trial in Europe, shortly. By building on the proprietary Dynaplasty technology, this device is designed to address recurrent mitral regurgitation, days, months or even years after the initial surgical procedure. The , enCorSQ technology allows recurrent mitral regurgitation to be managed on an out-patient basis, without the risk and cost of another cardiac surgery. European sales of enCorSQ are anticipated by second quarter of 2011. MiCardia plans to open an IDE for enCorSQ in Q1, 2011.
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