Pivotal Results For Medtronic’s CoreValve Reply

Key data on what will likely be the second transcatheter aortic valve to gain approval in the US were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) 2013 Conference in San Francisco. Jeffrey Popma, co-principal investigator of the Trial, presented the major results from the CoreValve U.S. Pivotal Trial in patients who were too ill or frail for traditional open heart surgery.

In an as-treated analysis of 471 patients (the intention-to-treat population was 487), the primary endpoint– the rate of death or major stroke at one year– was 25.5% (CI 21.6-29.4). This was 40.7% lower than the prespecified performance goal of 43% (p<0.0001) based on historical standards.

Click here to read the full post on Forbes.

 

 

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