Device Aids Repair of the Mitral Valve

A new investigational device is designed for the percutaneous endovascular repair of congestive heart failure (CHF)-related mitral valve regurgitation.

The PS3 system is configured to reshape the mitral valve annulus across the critical septal-lateral diameter, resulting in amelioration of the mitral valve regurgitation safely and effectively. The first human implants took place in June 2006. Performed at the University Hospital in Caracas (Venezuela), both implants were successful and marked the initiation of the clinical phase for the system. The system was implanted in the two patients prior to open heart surgery, and then removed during surgical intervention that included repair of the mitral valve with an annuloplasty ring.

"The tremendous success in the first two clinical patients duplicates the results achieved in pre-clinical studies where the safety and efficacy of the PS3 system was established in both ovine and porcine models,” said Dr. Reginald Low, professor of medicine and chief of the division of cardiovascular medicine at the University of California (Davis, USA).

"The PS3 system effectively reduced the septal-lateral diameter in both patients resulting in up to a three-grade reduction in mitral regurgitation,” explained lead surgeon Dr. Igor Palacios, director of interventional cardiology and the cardiac catheterization laboratories at Massachusetts General Hospital (Boston, USA).

The PS3 system was developed by Ample Medical (Foster City, CA, USA)