An effective non-surgical technique to repair a heart valve.
A new non-surgical technique avoiding an operation to open heart, can effectively repair with a clamp a mitral valve failure, according to the results of a clinical trial presented Sunday.
This EVEREST II study (Endovascular Valve Edge-to-Edge Repair Study) was conducted with 279 patients in the United States and Canada to compare the effectiveness of this procedure called MitraClip with that of conventional surgery.
It is being presented at the 59th annual conference of the American College of Cardiology which brings together some 30,000 cardiologists, researchers and representatives from all major pharmaceutical companies this weekend in Atlanta, Georgia, South.
The MitraClip, a kind of clothespin, is introduced through a catheter into the femoral artery and helps keep the mitral valve in place to prevent leakage.
This valve separates the left atrium from the left ventricle of the heart. Its failures affect millions of people around the world and are responsible for many deaths.
"As physicians, we saw our transformed patients, able to function after this procedure without a long stay in hospital or a long recovery period," says Dr. Ted Feldman, of NorthShore University in Evanston, Illinois , North), who conducted the study.
After one year, the clinical efficacy of MitraClip and open-heart valve repair surgery was considered comparable, depending on mortality, new malfunction of the mitral valve or significant leakage.
According to these criteria, the clinical success of MitraClip was obtained by 72.4% of patients treated with this technique compared to 87.8% of those who underwent surgery.
MitraClip also has the advantage of significantly reducing the risk associated with heavy surgery and is also much less expensive.
These positive results of the last phase of the clinical trial should lead in 2011 to the marketing authorization of MitraClip in the United States.
Already marketed in Europe, the MitraClip was developed by the Californian firm Evalve, acquired by the American pharmaceutical group Abbott in 2009.
The opening of the US market could result in potential annual sales totaling about $ 1 billion, according to market analysts. MitraClip is the only system of this type available