Medtronic, Inc. MDT today issued a statement on the results of two
studies evaluating the use of the Medtronic CoreValve System delivered
through the direct aortic implantation approach. Data presented at the Society
of Thoracic Surgeons 48th Annual Meeting demonstrate positive outcomes
when the CoreValve System is implanted using the direct aortic approach, which
received CE Mark in November 2011. The direct aortic
approach is also being evaluated in the Medtronic CoreValve U.S. Pivotal
Trial.
Data presented during a late-breaking session showed procedural success in 92
of 93 patients treated at 12 centers across Europe. There were no procedural
deaths, the overall 30-day mortality rate was 9.7 percent, and with experience
(after three cases) the 30-day mortality rate was 7.0 percent.
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