Edwards Lifesciences (NYSE:EW) won CE Mark approval in the European Union for the latest in its line of Sapien transcatheter aortic valve implantation systems, the company announced today.
The Sapien 3 device features an outer cuff of fabric designed to prevent valve leakage, and it’s the only commercially available TAVI device deliverable through the thinner 14 French expandable sheath, Edwards said.
The win did little for Edwards’ stock, with shares down 4.7% to $65.56 as of about 11:40 a.m. today. EW stock is down about 8.7% compared with 6 months ago.
The California medtech giant said earlier this month that it plans to "meet force with force" in defending its TAVI footprint against rival device makers, namely Medtronic (NYSE:MDT) and it’s CoreValve system.
Edwards chairman & CEO Michael Mussallem told an audience at the J.P. Morgan Healthcare conference early this month that it expects a "wild year" ahead in 2014 and that the company intends to defend its TAVI territory with a strong offense.
Mussallem said that Edwards will allow its sales reps to replace older Sapien devices already on the shelves with the newest models, including Sapien 3, without charging more for the new technology.
"Typically we would up-charge, but we think this is a critical year of competition," Mussallem said.
Edwards has taken many steps to defend its lead in the U.S. market and its footprint overseas. The device maker has been embroiled for years in a patent infringement tussle with rival Medtronic, in which Edwards has sought injunctions preventing Medtronic’s CoreValve system from reaching the market.
Medtronic just over a week ago won FDA approval to finally bring its CoreValve system to the U.S. market, and last week a federal appeals court ruled in Edwards’ favor to invalidate a Medtronic TAVI patent.
In July a German court ruled that Medtronic’s CoreValve TAVI infringes an Edwards Lifesciences patent, forcing Medtronic to cede the German market to Edwards and its Sapien valve. But in August the European Patent Office issued a preliminary, non-binding ruling that the Edwards patent at the center of the dispute in Germany is invalid. Medtronic resumed its German CoreValve sales in November.