Evercore Says Approval of Edwards' (EW) SAPIEN 3 Anticipated; Medtronic's CoreValve Expected in Early 2017

August 18, 2016 3:32 PM EDT
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Price: $83.21 -0.17%

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    26 Buy, 11 Hold, 1 Sell

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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)

For an analyst ratings summary and ratings history on Edwards Lifesciences click here. For more ratings news on Edwards Lifesciences click here.



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