Edwards Lifesciences is finally nearing the start of a pivotal study comparing its next-generation Sapien XT transcatheter aortic heart valve to surgery, with conditional FDA go-ahead for the trial announced Nov. 7.
The “cohort A” segment of Edwards’ PARTNER II trial will enroll a much lower-risk patient population compared to the firm’s first-generation Sapien device match-up against surgery, potentially opening the procedure...
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