CoreValve has expanded clinical evaluation of its ReValving System for percutaneous aortic valve replacement (PAVR) in high-risk patients with aortic stenosis is enrolling patients at 32 sites in 11 European countries.
The ReValving System procedures can be performed under local anesthesia, without the need for surgical cut-down/repair, and without hemodynamic support or artificially accelerating the heart rate, according to the Irvine, Calif.-based CoreValve.
According to CoreValve, more than 500 high-risk patients have been treated with its ReValving System for PAVR. The system has received European regulatory clearance in mid-2007.
The clinical results to date underscore the acute procedural benefits of PAVR for high-risk and inoperable patients, and demonstrate the potential for reduced hospital stays and for high quality-of-life patient outcomes, CoreValve said. The ReValving System bioprosthesis, designed for transcatheter delivery, will be followed for nearly three years in the octogenarian patient population.