TORONTO--(BUSINESS WIRE)--According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the introduction of transcatheter aortic valve replacement (TAVR) devices is expected to expand the treatable patient pool for valve replacement starting in 2011, contributing to a 6 percent average annual growth in heart valve procedures in the United States through 2015. By 2015, TAVR procedures are expected to make up almost 12 percent of all US heart valve procedures and TAVR devices will total over $565 million in revenue. The total heart valve device market will be valued at $1.26 billion.
TAVR devices, already available in Europe, have not yet received approval from the Food and Drug Administration (FDA) in the US. Three clinical trials are focused on the approval of TAVR devices; the most advanced being the PARTNER trial for Edwards Lifesciences’ SAPIEN valve. Edwards Lifesciences released preliminary findings from the PARTNER Cohort B trial in September 2010, which showed that TAVR therapy was superior to standard therapy in reducing patient mortality, as well as preliminary results in April 2011 showing TAVR therapy to be non-inferior to surgical aortic valve replacement for patients with high-risk aortic stenosis. The PARTNER II and the CoreValve trials are already testing Edwards Lifesciences’ second-generation SAPIEN XT valve and Medtronic’s CoreValve, respectively, for US approval. Approval of Edwards Lifesciences’ SAPIEN valve is expected by the end of 2011.
“These devices will permit patients who are ineligible for the current surgical techniques to get treatment,” said MRG Analyst Ian Swanson. “The response by US physicians has demonstrated both an excitement for the new technologies’ ability to treat a previously untreatable patient population, and some caution about any premature application of TAVR in patients who would otherwise be candidates for standard surgical aortic valve replacement.”
TAVR devices will carry a premium cost. If they are as popular as expected, they will serve as a substantial source of revenue for companies like Edwards Lifesciences and Medtronic.
Millennium Research Group’s US Markets for Heart Valve Devices 2011 report includes procedure, unit, average selling price and revenue information for tissue heart valves, mechanical heart valves, annuloplasty devices, TAVR devices and transcatheter mitral valve repair.
About Millennium Research Group
Millennium Research Group (www.MRG.net), a Decision Resources, Inc. company (www.DecisionResourcesInc.com), is the global authority on medical technology market intelligence and the leading provider of strategic information to the healthcare sector. The company provides specialized industry expertise through multiclient market research, ongoing Marketrack™ projects, customer loyalty tracking, facility-level procedure forecasting, and customized solutions.
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