The US dominates the transcatheter heart valve market with Edwards Lifesciences' Sapien

Press Release   •   Jun 10, 2013 10:20 BST

The US has been forecast to dominate the Transcatheter Heart Valve (THV) market, despite only entering the market in late 2011 with Edwards Lifesciences' Sapien.

The number of Transcatheter Aortic Valve Replacement (TAVR) procedures in the US has been forecast to climb from 7,946 in 2012 to 59,000 in 2017, driving the country's THV market from a value of $238 million to $1.9 billion by 2017.

Within one year, the US has managed to become the biggest country for THV sales, accounting for 28% of the global market in 2012 - 4% more than second-placed Germany. But while the initial FDA approval of Sapien only covered use on inoperable patients, the barrier was lowered last year to include those classified as high-risk.

This larger patient pool, says the report, will lead to the US claiming a massive 61% of worldwide THV revenue in 2017.

In Europe, the number of THV procedures performed more than quadrupled between 2009 and 2012, increasing from 5,000 to an estimated 25,000. Germany, France, UK, Spain and Italy accounted for more than 80%, with Germany alone making up more than 40% of all procedures carried out across the region over four years

The market will be driven by the increasing elderly population as a proportion of the general population, as this is a group that is at particular risk of developing heart valve disease due to aortic stenosis. Calcification and thickening of the aortic valve is found to occur in 2-4% of adults over the age of 65.

Currently, with more than 30 products in the pipeline, the transcatheter heart valve (THV) market is set to witness intense competition in the coming years. Though the first mover's advantage will be there for Edwards Lifesciences and Medtronic, the products in the pipeline are promising and are being developed with advanced features that the current products lack.

Features such as valve retrievability and repositioning will be a part of a new generation of THVs. There are promising products from Boston Scientific (Lotus Valve), St. Jude Medical (Portico) and Direct Flow Medical (Direct Floe Medical Valve) which are still undergoing clinical trials.

Advancements in material, size and delivery systems have helped surgeons to refine the procedures, leading to better post-surgical outcomes. Improvements in delivery systems with reduced sheath size will reduce vascular complications.

The approval of second-generation prosthetics and expanded approval for the use of TAVR in low to moderate-risk patients will maintain impressive growth rates in the near future.

For more information on the transcatheter heart valve market, see the latest research: Transcatheter Heart Valve Market

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