Transcatheter Valves At The Tipping Point

Edwards Lifesciences Corp. continues to compile clinical evidence for the safety and efficacy of its next-generation transcatheter aortic valve replacement (TAVR) devices and is expanding its global presence as competitors move closer to the US and non-US markets. Researchers presented late-breaking results from two trials at the 2013 American College of Cardiology (ACC) Annual Scientific Session last month in San Francisco that reflect favorably on both Edwards’ first-generation SAPIEN (the only US Food and Drug Administration-approved TAVR device, cleared in November 2011 for the treatment of inoperable patients, with the indication expanded to high-risk surgical patients in October 2012) and its second-generation, cobalt-chromium SAPIEN XT device with a new partially closed leaflet geometry, placed via the new lower-profile NovaFlex Delivery System. In addition, a first-in-human feasibility study has been published on the company's investigational, third-generation, balloon-expandable SAPIEN 3 device, delivered through a 14 French (14F) sheath, providing the first hints of that valve's potential for more accurate positioning and less post-procedure paravalvular (PV) regurgitation.

Meanwhile, the TAVR field continues to expand, with several next-generation devices expected to be launched in Europe this year and...