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Examples
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Doctors who saw him recommended the new procedure, known as transapical aortic valve replacement, because they thought that it was too risky for Bott to go through another open-heart surgery.
Medindia Health News 2009
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An alternate method, a transapical procedure, involves passing the valve through an incision between the ribs.
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The earlier data, released in November on 104 high-risk patients implanted using the transapical approach through the ribs, showed traditional open-heart surgery produced better results.
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"It is encouraging that, in this much larger group of patients treated with transapical valve replacement, investigators observed a trend toward patients feeling better faster and having improved outcomes," Edwards Chief Executive Michael Mussallem said in a statement.
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In addition to the transapical procedure, the company has developed a transfemoral approach in which the valve is threaded to the heart via a catheter inserted at the groin.
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"I think the Street will come away from it increasingly optimistic in Edwards' ability to get transapical past an FDA panel," said J.P. Morgan analyst Mike Weinstein in an e-mail.
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First of all on French imbursement, yes its in place, it's a two year reimbursement it refers to both transapical and transfemoral, we feel good about that there is a common period we will argue that the rate maybe should be a little larger.
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Procedures in France will be reimbursed that approximately EUR27,000 to EUR28,000 with coverage for both transapical and transfemoral approaches.
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As a reminder Cohort A compares randomized patients to either SAPIEN technology or surgery and includes the transapical approach.
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Two delivery methods for the Edwards SAPIEN XT valve will be evaluated in the trial -- the NovaFlex transfemoral and the Ascendra 2 transapical systems -- which are designed to make valve delivery and deployment easier for clinicians.
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