Medtech titan Edwards Lifesciences (NYSE:EW) today announced that it received CE Mark approval from European regulators to market its next-generation Sapien XT transcatheter valve system for either mitral or aortic valve-in-valve implantation.
Edwards is the only device maker with E.U. approval for transcatheter valve-in-valve implantation of the mitral valve, which is otherwise treated with open surgery, the company said. Mitral valve-in-valve procedures don’t represent a huge market, Edwards noted, but the win is an important one for patients.
"The European approval of the SAPIEN XT system for valve-in-valve procedures is a milestone achievement," transcatheter valves corporate vice president Larry Wood said in prepared remarks. "While this is not a large financial opportunity, it represents an important benefit for patients unable to go through a second open-heart surgery to replace their failing bioprosthetic valves."
The win marks another E.U. milestone for Edwards, which last week touted CE Mark approval for its Sapien 3 heart valve, which features a lower profile delivery sheath and an outer skirt to help prevent leakage.
The Sapien XT valve is not yet approved for the U.S., where Edwards’ original Sapien transcatheter aortic valve implantation system has been on the market since 2011. Rival minimally invasive valves maker Medtronic (NYSE:MDT) just last month won FDA approval to begin marketing its CoreValve implant, making it the 2nd medtech company to get a TAVI system on the U.S. market.
Edwards chairman & CEO Michael Mussallem told an audience at the J.P. Morgan Healthcare conference in January 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. Edwards last month won a $393 million judgment in a patent infringement lawsuit in Delaware, with Medtronic promising to appeal the verdict.
In July 2013 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 October the European Patent Office issued a preliminary, non-binding ruling invalidating the Edwards patent at the center of the German dispute.* Medtronic resumed its German CoreValve sales in November.
Corrected February 10, 2014. This article mistakenly stated that the European Patent Office decision was handed down in August.