Yesterday at EuroPCR 2009 in Barcelona, Edwards Lifesciences presented results of a clinical study evaluating the company’s SAPIEN transcatheter cardiac valve replacement system. In the study, the valve system was implanted using both transfemoral and transapical approaches.
The data showed a 30-day survival rate of 93.7 percent in transfemoral procedures (valve delivered via the femoral artery), and 89.7 percent in transapical procedures (valve delivered via a small incision between the ribs) — rates that were better than the predicted surgical survival in this high-risk patient cohort. Implant procedure safety with the Edwards SAPIEN valve was strongly demonstrated with low incidences of valve malposition (1.5 percent), coronary obstruction (0.6 percent), stroke (2.5 percent), conversion to surgery (2.7 percent), need for permanent pacemaker (7 percent), and significant aortic regurgitation (4.7 percent).
Also presented today was the first complete six-month data set of the 130 patients enrolled in the PARTNER EU clinical trial. The data demonstrated strong hemodynamics and valve performance through measurements including effective orifice area and ejection fraction, as well as 100 percent freedom from structural valve deterioration. PARTNER EU was designed to evaluate the Edwards SAPIEN valve in a setting where, for the first time, an interventional cardiologist and cardiac surgeon partnered to screen and determine the correct treatment approach for each patient.
Press release: Edwards Lifesciences Reports Positive Data From Its Largest Transcatheter Valve Implant Series
Device info page: Edwards SAPIEN Transcatheter Heart Valve
Flashbacks: Medtronic’s CoreValve Transcatheter Aortic Valve Replacement System Performs Well in Trial; SAPIEN Transcatheter Cardiac Valve Trial Going Ahead; Edwards Trials Company’s Minimally-Invasive Pulmonic Valve; Edwards Sapien Transcatheter Aortic Valve Makes Human Debut