Evercore Says Approval of Edwards' (EW) SAPIEN 3 Anticipated; Medtronic's CoreValve Expected in Early 2017
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Evercore ISI affirms Edwards Lifesciences (NYSE: EW) at Hold with a price target of $115 after the company announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 transcatheter heart valve for the treatment of patients suffering from severe, symptomatic aortic stenosis who have been determined by a Heart Team to be at intermediate risk for open-heart surgery.
Analyst Vijay Kumar noted that the approval was expected and that the FDA is mandating a 10-year follow up.
Kumar also commented on when Medtronic's (NYSE: MDT) CoreValve will be approved for IR patients. The analyst said,
MDT’s SURTAVI trial is a 2-year, prospective, randomized, controlled trial evaluating >1400 patients. The 2-year results are expected to be presented to ACC 2017 (March 2017). Key points include:
- Given that the S3 IR trial had a 1 year end point (with the control arm being a propensity matched cohort), it raises the question whether the FDA would consider an approval of the CoreValve system based on 1 year data (similar to S3)
- We know that the FDA lowered the sample size requirement for MDT’s SURTAVI trial from prior 2,000 to 1,400
- Also, subgroup analysis of CoreValve High Risk trial and data from the NOTION All-Comers prospective, randomized controlled trial has shown CoreValve to be superior in IR patients
- In light of the continued success of TAVR treatment (shown by multiple clinical trials), we wonder whether the FDA would consider 1 year data for approving CoreValve in IR patients. If so, this would be a surprise relative to investor expectations (general expectation is for 1H’2017 approval in US)
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