Medtronic Inc. (NYSE:MDT) and Edwards Lifesciences (NYSE:EW) got the thumbs up for their heart valves from U.K. researchers, but Edwards is two years ahead of Medtronic in bringing a device to the U.S. market.
Two-year follow-ups for Medtronic’s CoreValve and Edwards’ Sapien, both of which are approved in the U.K., were "encouraging" according to researchers.
Edwards, however, expects to land FDA clearance for Sapien "any day now," while Medtronic has called its CoreValve a "2014 product for the U.S."
The U.K. study included 877 transcatheter aortic valve implantation procedures performed between January 2007 and December 2009, TheHeart.org reported.
While mortality rates for all aortic valve patients were high, patients implanted transfemorally had lower risk of death at 30 days and at 1-2 years.
Between the two TAVI devices, CoreValve had lower mortality rates across the board, while patients implanted with the Sapien device had a lower rate of pacemaker use an the need for repeat procedures.
CoreValve also had a much higher incidence of aortic regurgitation, an important indicator of worse outcomes, TheHeart reported.