We are a quarter of the way into 2015 and TAVR already is jockeying to be the top story of the year.
Market reports can be less than transparent, which is a polite way to say questions can swirl around how thorough was the research, how rigorous was the methodology and how accurate was the information coming in and flowing out. They may include assumptions. Even the best can’t anticipate curve balls that might change their projections, either a little or a lot.
Zigzagging regulation, recalls, patent wars and class action lawsuits potentially can influence practice and impact the marketplace. Transcatheter aortic valve replacement (TAVR) is not immune to these possibilities—although the patent skirmish between Edwards Lifesciences and Medtronic has been put to rest. That is good, because in the U.S. it allowed the two FDA-approved TAVR systems to remain available for inoperable and high-risk patients with severe aortic stenosis.
A recent market report predicted that sales of TAVR valves in the U.S., Germany, France, Italy, Spain, the U.K., Japan, Brazil, China and India would grow from $881 million in 2013 to exceed $3 billion in 2020. The numbers may not pass the test of time, but the upward trajectory likely will.
This week the FDA widened the indication for Medtronic’s CoreValve to be used in valve-in-valve procedures. The agency wrote in a statement the device provides an “option for a significant number of patients” whose surgical valves failed and who no longer are suitable for a second surgery.
The American College of Cardiology’s scientific session in March was a bit of a TAVR fest, with late-breaking clinical trials reporting results CoreValve at two years and the Sapien valve at five years. Another study looked at the Sapien 3 valve at 30-days. All of these presentations supported the use of TAVR in the various patient populations studied.
Ajay J. Kirtane, MD, SM, from the Center for Interventional Vascular Therapy and chief academic officer at Columbia University Medical Center in New York City, may have articulated what many of his colleagues were thinking at the conference: “For the field as a whole, we have reached a sort of tipping point now where you can begin to start asking the question, who shouldn’t get TAVR and who should be offered surgery,” he said during an interview.
We plan to explore that question in the July/August issue of Cardiovascular Business. Be sure to sign up here, if you haven’t already, to receive the magazine.
Editor, Cardiovascular Business