A new report is projecting that the transcatheter aortic valve replacement procedure will be the single-most dominant force driving the U.S. market for heart valves to more than $1.5 billion in 2016.
That compares to a market value of $610 million in 2011, according to Ian Swanson, an analyst with the Millennium Research Group, which issued the report. In other words, a nearly 146 percent jump in five years.
The only TAVR procedure approved in the U.S. is Edwards Lifesciences’ SAPIEN system. In November, the U.S. Food and Drug Administration approved the product for patients with severe aortic stenosis who were too sick to undergo open-heart surgery. And earlier in June, an FDA panel recommended that the agency approve the procedure for patients who face a high risk if they underwent open-heart surgery.
If the agency approves the expanded indication, Edwards will have a product using two different approaches in its portfolio — the transfemoral and the transapical approach, which is through the ribs.
Meanwhile, Medtronic is still recruiting patients for its CoreValve TAVR system., The report said that Edwards’ next-generation product – SAPIEN XT — will hit the market before CoreValve is expected to make its debut in 2014. The report also predicted that the FDA will approve TAVR for even more patients as a clearer clinical picture emerges for these types of devices.
As the volume of TAVR procedures increase, there will be a slight decrease in that of surgical valve replacement.