The transcatheter aortic valve replacement market continues its upward trend, as both Edwards Lifesciences Corp. and Medtronic PLC posted recent gains in this area. During Edwards' recent Q1 conference call, CEO Michael Mussallem said the firm's Sapien valve, which is marketed in Europe, continues to exceed expectations and is "increasingly becoming a standard of care for aortic stenosis patients at high-risk for surgery." Sapien pulled in sales of $39.1 million in the quarter, up 59% year-over-year. The company anticipates full-year 2010 Sapien sales will reach the high end of its $170-$190 million guidance. That would represent significant growth over 2009 Sapien sales of $112 million. Edwards now predicts the worldwide transcatheter valve opportunity will exceed $2 billion by 2014, which is a substantial increase over previous estimates. ( See Exhibit 1.)
In March, Edwards received CE mark approval for its second-generation, lower-profile Sapien XT, delivered on the firm's new 18-French NovaFlex Transfemoral Delivery System, and initiated a controlled European launch of...
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