The development of 3-D transesophageal echo (TEE) just a few years ago has enabled a new generation of interventional procedures to be performed, which otherwise...
Abbott announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted by majority (Yes: 5, No: 3) that the benefits...
The three-year results of a pivotal clinical study comparing the Edwards Sapien transcatheter heart valve and open-heart surgery demonstrated comparable outcomes. These new data from The PARTNER...
Edwards Lifesciences Corporation announced that preliminary results from The PARTNER II Trial demonstrated similar one-year outcomes in mortality and major clinical events between the Edwards...
Boston Scientific reports preliminary data in the PREVAIL clinical trial met two out of three co-primary endpoints. The data was supposed to be presented during the 2013 American College of...
March 13, 2013 — St. Jude Medical Inc. announced the first patient implant in a new pivotal trial evaluating the company’s Amplatzer cardiac plug (ACP) for the prevention of stroke.
March 7, 2013 — Philips Healthcare announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EchoNavigator live image-guidance tool.
Medtronic Inc. announced European CE (Conformité Européenne) mark approval for its Engager Transcatheter Aortic Valve Implantation (TAVI) System with transapical delivery catheter. The system...