Edwards Lifesciences (Irvine, California) investors seemed to breathe a collective sigh of relief Monday afternoon when the company released data at the Society of Thoracic Surgeons (STS; Chicago) that restored confidence in the transapical approach (TA) for delivering the company's Sapien transcatheter heart valve to high-risk surgical patients with severe aortic stenosis. These patients were treated during the continued access period (CAP) of Cohort A of the PARTNER trial.
Medtronic (Minneapolis) reported FDA approval and launch of the DF4 High-Voltage Connector System, a right ventricular lead and connector used with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) to detect and accurately treat potentially life-threatening heart rhythms. The DF4 Connector System helps simplify implantation procedures via a redesigned port and provides additional reliability by giving physicians visual confirmation of the lead connection to the device. (Medical Device Daily)