Mitral Valve for Common Diseases Introduced
Edwards Lifesciences announced approval from the Food and Drug Administration for the company’s new Carpentier-Edwards PERIMOUNT Magna mitral heart valve. Plans to immediately introduce the device across the United States were detailed in the company’s press release. The company’s PERIMOUNT Magna mitral valve was already approved in Europe almost three years ago.
The bioprosthetic device is based on bovine pericardial tissue used to replace a diseased valve. It features a unique, asymmetric shape. This was chosen to mimic the natural anatomy of the mitral valve. The new valve offers the lowest ventricular projection and lowest effective profile of the devices available on the market.
Another advantageous feature of the device is an expansive sewing cuff. This supports valve implantation in challenging locations. Additional features support hemodynamic performance.
This new valve is indicated to treat those patients who suffer from mitral valve disease. This is one of the most common types of valvur disease throughout the world. In the U.S. alone, estimates suggest that between 35,000 and 40,000 patients will undergo valve replacement in this year alone.
Edwards specializes in the development of heart valves and tools to support hemodynamic monitoring. The company has over fifty years of experience in creating such tools.
September 5, 2008 Related topics: Product Approval & Certification, New Technology & Innovation, Cardiology