Edwards Set To Launch “Two-Trials-In-One” For Sapien Percutaneous Valve
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences will soon begin a 600-patient U.S. pivotal clinical trial for its Sapien transcatheter aortic replacement heart valve at Columbia University Medical Center and the Cleveland Clinic, the company says
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Edwards Lifesciences transcatheter heart valve gains European market go-ahead
Edwards will launch its Sapien transcatheter aortic heart valve in Europe in the fourth quarter following CE mark clearance, announced Sept. 5. The device is indicated for patients at high risk for open surgery. While the initial clearance covers use of Sapien with the firm's RetroFlex transfemoral delivery system, Edwards expects expanded approval by year end for use with its Ascendra transapicaldelivery system. The approval reportedly sets the stage for projected Sapien sales of over $20 million in 2008. A U.S. trial also is underway (1"The Gray Sheet" March 26, 2007, p. 10). Competitor CoreValve gained European approval of its ReValving percutaneous aortic valve in May, but has not yet fully commercialized the product (2"The Gray Sheet" May 21, 2007, In Brief). CoreValve also has a transapical system in development...
Edwards Lifesciences transcatheter heart valve gains European market go-ahead
Edwards will launch its Sapien transcatheter aortic heart valve in Europe in the fourth quarter following CE mark clearance, announced Sept. 5. The device is indicated for patients at high risk for open surgery. While the initial clearance covers use of Sapien with the firm's RetroFlex transfemoral delivery system, Edwards expects expanded approval by year end for use with its Ascendra transapicaldelivery system. The approval reportedly sets the stage for projected Sapien sales of over $20 million in 2008. A U.S. trial also is underway (1"The Gray Sheet" March 26, 2007, p. 10). Competitor CoreValve gained European approval of its ReValving percutaneous aortic valve in May, but has not yet fully commercialized the product (2"The Gray Sheet" May 21, 2007, In Brief). CoreValve also has a transapical system in development...
Edwards’ percutaneous valve
Edwards Lifesciences' "single largest investment increase" in the near term is to accelerate the European launch of its Sapien transcatheter heart valve, says CEO Michael Mussallem July 23 during the firm's 2007 second quarter earnings call. Edwards anticipates gaining CE mark for the device in time for year-end introduction. Competitor CoreValve (ReValving) got European approval in May. Edwards hopes to launch Sapien in the United States by 2010 (1"The Gray Sheet" March 26, 2007, p. 10). The company is also reinforcing its U.S. heart valve sales force in anticipation of FDA-approval of the Magna mitral tissue valve this year. But with timing of the Magna approval uncertain, the company is advising that its full year 2007 revenues will be on the low end of previous guidance of $1.07 billion to $1.11 billion, with heart valve sales in the second half of 2007 between $250 million and $260 million...