According to researchers Sunday, Abbott Laboratories experimental, minimally invasive heart valve device meant for repairing the commonest kind of heart valve problems, has met the primary goals of a pivotal study which found it to be safer and almost as effective as open heart surgery.
 
Abbott, whose mitral valve device - MitraClip has been available in Europe for about 18 months, now hopes to use the study data to win U.S. approval.  Actress Elizabeth Taylor, 77, who got one last fall, told fans about it on Twitter.
 
The Abbott device in the first large trial of its kind, wherein researchers compared the Abbott device with open heart surgery for treating mitral regurgitation, with the device delivered to the heart via a catheter through a blood vessel in the leg.
 
The study compared the number of major adverse events (around 12) that took place in a 30 day period, including major stroke, urgent cardiovascular surgery, re-operation of mitral valve, heart attack, major bleeding, kidney failure and death.
 
In what is considered to be a highly statistical difference, only 9.6% of patients who received the MitraClip suffered major adverse events, as compared with 57% in the surgery group.  Of the 55 adverse events in the surgery group, 42 were major bleeding, researchers said.
 
Over 8 million people in the United States and Europe are affected by MR i.e. a faulty mitral valve that does close properly, allowing blood to flow backward in to the heart.  A debilitating condition, MR causes the heart’s ability to function to deteriorate over time leading to stroke, heart failure, an irregular heartbeat, heart attack or death.
 
The device’s effectiveness was measured by the lack of need for surgery for valve dysfunction at one year, with the device attaining the effectiveness goal in 72.4% of patients compared with 87.8% among surgery patients.
 
One year after patients with significant MR received the MitraClip, they demonstrated improvement in heart function, quality of life, and normal physical activity, including a decrease in cardiac symptoms.
 
Every year, over 250,000 cases of significant MR are diagnosed in the USA and if the device is approved by next year, it could become a $1 billion a year product for Abbott.  The device sells for $27,000 in Europe, exclusive of what doctors and hospital charge to implant it.  Valve surgery costs $50,00, including a longer stay in hospital.
 
Doctors called the study a watershed, the first big test of repairing or replacing heart valves through arteries rather than drastic surgery.