|Sapien 3 valve--Courtesy of Edwards Lifesciences|
Edwards Lifesciences ($EW) estimated the transcatheter aortic valve replacement (TAVR) market as worth more than $5 billion by 2021. That's based on its expectation of an expansion into elderly and intermediate-risk populations. Last year, its Sapien 3 valve was approved by the FDA specifically for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis.
The heart disease and critical care company expects data from a Sapien 3 trial in intermediate risk patients within the next few months--with an FDA approval in that indication potentially secured this year. But the company said it has not yet factored an intermediate-risk FDA approval for Sapien 3 into its 2016 sales guidance.
In addition, Edwards is slated to start a 1,300-patient trial of Sapien 3 during the second quarter specifically in elderly patients who are at low risk of mortality. The study, dubbed PARTNER III, is expected to be a noninferiority, randomized study against open heart surgery with a one-year composite endpoint that includes death, stroke and rehospitalization. It will include a 400-patient sub-group study on the use of imaging to evaluate leaflet motion in tissue heart valves.
|Larry Wood, Edward VP of transcatheter heart valves|
"If this trial is successful, it will allow heart teams to choose a treatment approach that is best suited to every patient's individual need," said Larry Wood, Edwards VP of transcatheter heart valves, in a statement. "We are pleased to begin this important study of the Sapien 3 transcatheter valve to evaluate its safety and effectiveness in a broader group of elderly patients suffering from this deadly disease."
Edwards had only good news about Sapien 3 at its recent presentation at the J.P. Morgan Healthcare Conference in San Francisco.
"As we think about this opportunity, the deeper that we've gotten into it and the more success that we've enjoyed, we're starting to believe that this opportunity is even bigger than we thought it was before. We have increased our estimate of the opportunity to one that could exceed $5 billion by 2021," said Edwards Chairman and CEO Michael Mussallem.
He added, "That's based on a lot of evaluation that we've done and a lot of what we've learned about by introducing transcatheter heart valves. In the past, our notion of how many patients there were and how big the opportunity were, were shaped by surgery. … But it's dramatically more prevalent in the elderly than it is in younger patients."
Edwards has guided to 2016 global sales of $2.5 billion to $2.75 billion; that would be growth of 7% to 11%. It's pegged 2016 adjusted EPS at $2.30 to $2.40 per share. In 2016, it expects $1.2 billion to $1.4 billion in transcatheter heart valve therapies sales, an increase of 10% to 18%.
- here is the elderly, low-risk trial announcement