Edwards’ Perimount Magna Mitral Valve Replacement Gets FDA Approval
By Adam Pick on September 16, 2008
More news from the leading heart valve manufacturer this week…
According to Reuters, Edwards Lifesciences Corp said won U.S. regulatory approval for a device to replace diseased mitral valves, one of the most common forms of heart valve abnormalities (including mitral valve prolapse).
Edwards’ Perimount Magna mitral valve replacement will be launched in the United States immediately, making Edwards the only company to have a bovine pericardial mitral valve replacement on the U.S. market.
As you may know, mechanical valves last longer than tissue valves, but patients with mechanical replacement valves must take a blood thinner, like Coumadin. Alternatively, tissue valves are more convenient and those derived from cows are perceived by some physicians to last longer than those from pigs. For more on the pros and cons of mechanical and bioprosthetic valves, click here.
Medtronic and St. Jude Medical also compete in the mitral valve market with a mix of mechanical valves and valves made from pig / cow tissue. Edwards, an Irvine, California-based company, posted total sales of $1.1 billion in 2007.
According to industry estimates, there will be 35,000 to 40,000 surgical mitral valve replacements in the United States this year to correct defect valvular disorders like mitral valve prolapse.
Keep on tickin!
jeanne baykara says on January 3rd, 2009 at 9:42 pm
I had a mitral valve replaced 29 months ago with cow. There has been mild regering since but I feel fine. Is this a sign that a replacement will be needed soon?