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Edwards’ Success With Go-Slow Sapien Launch

Transcatheter heart valves (TAVI) arrived in Europe in 2007 with the introduction of Medtronic PLC’s CoreValve, followed shortly thereafter by Edwards Lifesciences Corp.’s Sapien. (SeeAlso see "CoreValve: A Surgeon Moves Heart Valves to the Cath Lab" - In Vivo, 1 March, 2007., [A#2012800185] andAlso see "Edwards: Transcatheter Valve Leader Proves You Can Go Home Again " - In Vivo, 1 November, 2010..) Designed to treat patients with severe, symptomatic aortic stenosis, these innovative therapies have the potential to treat inoperable patients and eventually those considered high-risk for traditional surgery, creating market potential of $10+ billion per year.

In the US, Edwards had a sizeable head start, launching in late 2011, while competitors were still seeking regulatory approval....

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