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Edwards Plans To Keep ‘First-Mover’ Advantage In TAVI Against Emerging Competition

Edwards is counting on the Sapien XT valve, which will likely earn FDA approval soon, to compete with Medtronic’s recently approved CoreValve in the U.S, while in Europe the company is working quickly to upgrade customers to Sapien 3.

Edwards Lifesciences Corp. provided some details on its strategy to remain the leader in the increasingly competitive transcatheter aortic valve implant (TAVI) market during its fourth-quarter 2013 earnings call on Feb. 3.

Edwards’ Sapien system has had the U.S. market all to itself since 2011, but now faces tough competition from

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Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
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Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
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Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

Newborn Screening Tests Among FDA Classifications

 
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Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 
• By Brian Bossetta

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?